Trial Outcomes & Findings for Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology (NCT NCT03092518)

NCT ID: NCT03092518

Last Updated: 2025-02-19

Results Overview

OS is defined as the median amount of time a participant survives after therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 53.7 months
• Results posted on: 2025-02-19

Participant Flow

Participant milestones

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).
Overall Study STARTED	27
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).

Overall Study Ineligible

2

Baseline Characteristics

Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

Baseline characteristics by cohort

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=27 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	47.81 years STANDARD_DEVIATION 13.61 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 53.7 months

Population: 25/27 participants were analyzed because 2 were deemed ineligible.

OS is defined as the median amount of time a participant survives after therapy.

Outcome measures

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=25 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).	Non-Serious All treatment related non-serious adverse events.
Overall Survival (OS)	11.96 Months Interval 5.42 to 19.71	—

SECONDARY outcome

Timeframe: 6 months, 12 months and 18 months

Population: 25/27 participants were analyzed because 2 were deemed ineligible.

Intraperitoneal progression free survival is defined as the median amount of time a participant survives from date of operation (hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy) without intraperitoneal disease progression after treatment. Intraperitoneal progression is defined as new, large volume ascites with or without associated peritoneal nodularity or thickening determined by radiographic imaging, cytopathology or histopathology.

Outcome measures

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=25 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).	Non-Serious All treatment related non-serious adverse events.
Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months 6 months	0.9 Months Interval 0.65 to 0.97	—
Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months 12 months	0.83 Months Interval 0.54 to 0.94	—
Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months 18 months	0.83 Months Interval 0.54 to 0.94	—

SECONDARY outcome

Timeframe: 48.9 months

Population: 25/27 participants were analyzed because 2 were deemed ineligible.

Extra-peritoneal disease-free survival is defined as the median amount of time a participant survives from date of surgery to the date of first observation of progressive disease at sites other than the peritoneal surface (e.g., liver, intra-abdominal lymph nodes, abdominal wall soft tissues, and any other solid organs) determined by radiographic imaging (i.e., computed tomography, magnetic resonance imaging, and/or positron emission tomography).

Outcome measures

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=25 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).	Non-Serious All treatment related non-serious adverse events.
Extra-peritoneal Disease-free Survival	48.9 Months Interval 0.0 to 48.9	—

SECONDARY outcome

Timeframe: Up to 1646 days

Population: 2/27 participants were deemed ineligible prior to treatment.

The number of treatment related serious and/or non-serious adverse events by type related to research treatments was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=25 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).	Non-Serious n=25 Participants All treatment related non-serious adverse events.
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Serum amylase increased	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Sinus bradycardia	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Sinus tachycardia	3 adverse events	11 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Small intestinal obstruction	3 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Sore throat	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Upper gastrointestinal hemorrhage	2 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Urinary tract infection	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Vaginal anastomotic leak	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Vomiting	0 adverse events	8 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Weight loss	2 adverse events	6 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type White blood cell decreased	1 adverse events	5 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Acute kidney injury	1 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Alanine aminotransferase increased	0 adverse events	15 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Alkaline phosphatase increased	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Anemia	12 adverse events	69 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Anorexia	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Anxiety	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type abdominal distension	0 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Abdominal infection	2 adverse events	4 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Ascites	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Aspartate aminotransferase	0 adverse events	21 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Aspiration	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Atelectasis	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Atrial fibrillation	4 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Atrial flutter	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Abdominal pain	1 adverse events	18 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Back pain	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Acidosis	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Bladder perforation	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Activated partial thromboplastin time prolonged	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Bloating	0 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Blood bilirubin increased	0 adverse events	8 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type CPK increased	0 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Chest wall pain	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Colitis	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Confusion	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Cough	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Creatinine increased	1 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Cystitis noninfective	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Dehydration	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Depressed level of consciousness	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hyperglycemia	0 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Depression	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Diarrhea	0 adverse events	5 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Disseminated intravascular coagulation	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Dizziness	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Duodenal fistula	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Dyspnea	5 adverse events	4 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Edema limbs	0 adverse events	6 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Esophageal anastomotic leak	2 adverse events	4 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Esophagitis	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Fatigue	0 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Fever	1 adverse events	12 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Gastrointestinal anastomotic leak	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Headache	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hematuria	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hiccups	0 adverse events	5 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hyperkalemia	1 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypernatremia	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypertension	2 adverse events	8 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypoalbuminemia	1 adverse events	30 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypocalcemia	0 adverse events	7 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypokalemia	1 adverse events	4 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hyponatremia	2 adverse events	3 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypophosphatemia	0 adverse events	48 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypotension	4 adverse events	15 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pleural effusion	9 adverse events	4 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypothermia	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Hypoxia	1 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Infections and infestations-other	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Insomnia	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Intraoperative urinary injury	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Lung infection	3 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Lymphocyte count decreased	0 adverse events	44 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Malaise	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Mediastinal infection	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Metabolism and nutrition disorders other	1 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Nausea	0 adverse events	11 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Neutrophil count decreased	0 adverse events	2 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Oral pain	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pain	0 adverse events	10 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pain in extremity	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pericardial effusion	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Platelet count decreased	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pleural infection	2 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Pneumothorax	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Productive cough	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Renal and urinary disorders-other	0 adverse events	1 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Respiratory failure	5 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Respiratory, thoracic and mediastinal disorders-other	4 adverse events	0 adverse events
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type Sepsis	5 adverse events	1 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Document adverse events from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days

Population: 25/27 participants were analyzed because 2 were deemed ineligible.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=25 Participants Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).	Non-Serious All treatment related non-serious adverse events.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	23 Participants	—

Adverse Events

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Serious events: 10 serious events

Other events: 23 other events

Deaths: 23 deaths

Serious adverse events

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=27 participants at risk Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).
Infections and infestations Abdominal infection	3.7% 1/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Renal and urinary disorders Acute kidney injury	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Blood and lymphatic system disorders Anemia	18.5% 5/27 • Number of events 12 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Ascites	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Aspiration	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Atrial fibrillation	7.4% 2/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Atrial flutter	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Creatinine increased	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Nervous system disorders Depressed level of consciousness	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Blood and lymphatic system disorders Disseminated intravascular coagulation	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Duodenal fistula	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.4% 2/27 • Number of events 5 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Injury, poisoning and procedural complications Esophageal anastomotic leak	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Esophagitis	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Fever	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hyperkalemia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Vascular disorders Hypertension	3.7% 1/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypoalbuminemia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypokalemia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hyponatremia	3.7% 1/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Vascular disorders Hypotension	7.4% 2/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Hypothermia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Infections and infestations - Other, Bacteremia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Lung infection	7.4% 2/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Malaise	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Mediastinal infection	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, Lactic Acidosis	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	18.5% 5/27 • Number of events 9 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Pleural infection	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 3/27 • Number of events 5 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Tachypnea	7.4% 2/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Sepsis	14.8% 4/27 • Number of events 5 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Sinus bradycardia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Sinus tachycardia	7.4% 2/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Small intestinal obstruction	7.4% 2/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.7% 1/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Weight loss	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations White blood cell decreased	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.

Other adverse events

Measure	Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer n=27 participants at risk Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours. Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated). Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up. Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated. Electrocardiogram (EKG): At screening and baseline (if not done at screening).
Gastrointestinal disorders Abdominal distension	11.1% 3/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Abdominal infection	14.8% 4/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Abdominal pain	37.0% 10/27 • Number of events 19 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Acidosis	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Activated partial thromboplastin time prolonged	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Renal and urinary disorders Acute kidney injury	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Alanine aminotransferase increased	40.7% 11/27 • Number of events 15 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Alkaline phosphatase increased	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Blood and lymphatic system disorders Anemia	81.5% 22/27 • Number of events 71 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Anorexia	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Psychiatric disorders Anxiety	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Ascites	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Aspartate aminotransferase increased	48.1% 13/27 • Number of events 21 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Atelectasis	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Musculoskeletal and connective tissue disorders Back pain	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Hepatobiliary disorders Bladder perforation	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Bloating	11.1% 3/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Blood bilirubin increased	11.1% 3/27 • Number of events 8 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations CPK increased	11.1% 3/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Musculoskeletal and connective tissue disorders Chest wall pain	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Colitis	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Psychiatric disorders Confusion	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Creatinine increased	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Renal and urinary disorders Cystitis noninfective	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Psychiatric disorders Depression	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Diarrhea	11.1% 3/27 • Number of events 5 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Nervous system disorders Dizziness	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 3/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Edema limbs	14.8% 4/27 • Number of events 6 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Injury, poisoning and procedural complications Esophageal anastomotic leak	14.8% 4/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Fatigue	14.8% 4/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Fever	29.6% 8/27 • Number of events 14 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Nervous system disorders Headache	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Renal and urinary disorders Hematuria	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Hiccups	7.4% 2/27 • Number of events 5 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hyperglycemia	11.1% 3/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hyperkalemia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypernatremia	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Vascular disorders Hypertension	14.8% 4/27 • Number of events 8 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypoalbuminemia	51.9% 14/27 • Number of events 30 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypocalcemia	22.2% 6/27 • Number of events 7 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypokalemia	14.8% 4/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hyponatremia	7.4% 2/27 • Number of events 3 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Metabolism and nutrition disorders Hypophosphatemia	59.3% 16/27 • Number of events 48 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Vascular disorders Hypotension	40.7% 11/27 • Number of events 16 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Psychiatric disorders Insomnia	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Injury, poisoning and procedural complications Intraoperative urinary injury	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Lung infection	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Lymphocyte count decreased	51.9% 14/27 • Number of events 44 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Nausea	25.9% 7/27 • Number of events 12 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Neutrophil count decreased	11.1% 3/27 • Number of events 4 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Oral pain	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
General disorders Pain	33.3% 9/27 • Number of events 10 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Pericardial effusion	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Platelet count decreased	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	22.2% 6/27 • Number of events 6 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Productive cough	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Renal and urinary disorders Renal and urinary disorders - Other, Urinary Leak	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Sepsis	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Serum amylase increased	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Cardiac disorders Sinus tachycardia	29.6% 8/27 • Number of events 11 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Respiratory, thoracic and mediastinal disorders Sore throat	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Vascular disorders Thromboembolic event	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Infections and infestations Urinary tract infection	7.4% 2/27 • Number of events 2 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Injury, poisoning and procedural complications Vaginal anastomotic leak	3.7% 1/27 • Number of events 1 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Gastrointestinal disorders Vomiting	14.8% 4/27 • Number of events 8 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations Weight loss	14.8% 4/27 • Number of events 6 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.
Investigations White blood cell decreased	22.2% 6/27 • Number of events 7 • All-Cause Mortality monitored/assessed up to 53.7 months. Adverse Events monitored/assessed from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days.

Additional Information

Dr. Jeremy Davis

National Cancer Institute

Phone: 2408583731

Email: jeremy.davis@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place