Trial Outcomes & Findings for Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer (NCT NCT03579771)
NCT ID: NCT03579771
Last Updated: 2025-08-15
Results Overview
Completion of all therapy rate will be recorded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 12 weeks after study start
Results posted on
2025-08-15
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Age, Continuous
|
61.17 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Benaroya Research Institute at Virginia Mason
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Emory University
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
MD Anderson
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Mayo Clinic-Rochester
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks after study startCompletion of all therapy rate will be recorded.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Number of Participants Who Completed All Preoperative and Operative Therapy
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years after study startWill be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
26 participants
|
|
Number of Participants With Adverse Events
Blood and lymphatic system disorders
|
13 participants
|
|
Number of Participants With Adverse Events
Ear and labyrinth disorders
|
2 participants
|
|
Number of Participants With Adverse Events
Endocrine disorders
|
1 participants
|
|
Number of Participants With Adverse Events
Gastrointestinal disorders
|
11 participants
|
|
Number of Participants With Adverse Events
General disorders and administration site conditions
|
11 participants
|
|
Number of Participants With Adverse Events
Investigations
|
15 participants
|
|
Number of Participants With Adverse Events
Metabolism and nutrition disorders
|
4 participants
|
|
Number of Participants With Adverse Events
Nervous system disorders
|
9 participants
|
|
Number of Participants With Adverse Events
Renal and urinary disorders
|
1 participants
|
|
Number of Participants With Adverse Events
Respiratory, thoracic and mediastinal disorders
|
4 participants
|
|
Number of Participants With Adverse Events
Skin and subcutaneous tissue disorders
|
13 participants
|
|
Number of Participants With Adverse Events
Vascular disorders
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 12 weeks after study startPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Radiological Response Rate Defined as the Percentage of Patients Who Will Have Complete Response (CR), Partial Response (PR) or Stable Disease (SD) After the Neoadjuvant Therapy
PD
|
3 Participants
|
|
Radiological Response Rate Defined as the Percentage of Patients Who Will Have Complete Response (CR), Partial Response (PR) or Stable Disease (SD) After the Neoadjuvant Therapy
PR
|
7 Participants
|
|
Radiological Response Rate Defined as the Percentage of Patients Who Will Have Complete Response (CR), Partial Response (PR) or Stable Disease (SD) After the Neoadjuvant Therapy
SD
|
20 Participants
|
SECONDARY outcome
Timeframe: From the date of surgery up to 3 yearsRFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Recurrence-free Survival (RFS)
|
23.7 months
Interval 17.1 to 37.1
|
SECONDARY outcome
Timeframe: From date of neoadjuvant treatment start up to 3 yearsOS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 Participants
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Number of Participants With Overall Survival
|
30 Participants
|
Adverse Events
Gemcitabine, Cisplatin, Nab-paclitaxel
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 participants at risk
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • 3 years
|
|
Investigations
Neutrophil count decreased
|
16.7%
5/30 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • 3 years
|
|
Investigations
White blood cell decreased
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • 3 years
|
|
General disorders
Dehydration
|
3.3%
1/30 • 3 years
|
|
Investigations
Hypophosphatemia
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
1/30 • 3 years
|
Other adverse events
| Measure |
Gemcitabine, Cisplatin, Nab-paclitaxel
n=30 participants at risk
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Cisplatin: Given IV
Gemcitabine: Given IV
Nab-paclitaxel: Given IV
|
|---|---|
|
General disorders
Fatigue
|
66.7%
20/30 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
43.3%
13/30 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
43.3%
13/30 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
13/30 • 3 years
|
|
Endocrine disorders
Hyperglycemia
|
40.0%
12/30 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
40.0%
12/30 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
10/30 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
9/30 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
9/30 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.7%
8/30 • 3 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
26.7%
8/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.7%
8/30 • 3 years
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
26.7%
8/30 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
23.3%
7/30 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
6/30 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
6/30 • 3 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
20.0%
6/30 • 3 years
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30 • 3 years
|
|
General disorders
Dizziness
|
16.7%
5/30 • 3 years
|
|
Gastrointestinal disorders
Dyspnea
|
16.7%
5/30 • 3 years
|
|
Cardiac disorders
Hypertension
|
16.7%
5/30 • 3 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
5/30 • 3 years
|
|
General disorders
Pain
|
16.7%
5/30 • 3 years
|
|
Eye disorders
Blurred vision
|
13.3%
4/30 • 3 years
|
|
Blood and lymphatic system disorders
Edema limbs
|
13.3%
4/30 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
3/30 • 3 years
|
|
Investigations
Hypokalemia
|
10.0%
3/30 • 3 years
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
10.0%
3/30 • 3 years
|
|
Infections and infestations
Mucositis oral
|
10.0%
3/30 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
3/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
6.7%
2/30 • 3 years
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • 3 years
|
|
Ear and labyrinth disorders
Epistaxis
|
6.7%
2/30 • 3 years
|
|
Infections and infestations
Febrile neutropenia
|
6.7%
2/30 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
2/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • 3 years
|
|
Cardiac disorders
Hypotension
|
6.7%
2/30 • 3 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
6.7%
2/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
2/30 • 3 years
|
|
Infections and infestations
Sore throat
|
6.7%
2/30 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • 3 years
|
|
Gastrointestinal disorders
Weight loss
|
6.7%
2/30 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • 3 years
|
|
Ear and labyrinth disorders
Bronchial infection
|
3.3%
1/30 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.3%
1/30 • 3 years
|
|
General disorders
Chills
|
3.3%
1/30 • 3 years
|
|
Infections and infestations
Colitis
|
3.3%
1/30 • 3 years
|
|
Infections and infestations
Cough
|
3.3%
1/30 • 3 years
|
|
General disorders
Dehydration
|
3.3%
1/30 • 3 years
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Dysgeusia
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Erythema multiforme
|
3.3%
1/30 • 3 years
|
|
General disorders
Flushing
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • 3 years
|
|
General disorders
Headache
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
3.3%
1/30 • 3 years
|
|
Endocrine disorders
Hypoglycemia
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
3.3%
1/30 • 3 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.3%
1/30 • 3 years
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
3.3%
1/30 • 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.3%
1/30 • 3 years
|
|
Investigations
Investigations - Other, specify
|
3.3%
1/30 • 3 years
|
|
Ear and labyrinth disorders
Laryngeal inflammation
|
3.3%
1/30 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
1/30 • 3 years
|
|
Injury, poisoning and procedural complications
Localized edema
|
3.3%
1/30 • 3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.3%
1/30 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.3%
1/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Movements involuntary
|
3.3%
1/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.3%
1/30 • 3 years
|
|
General disorders
Myalgia
|
3.3%
1/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.3%
1/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
3.3%
1/30 • 3 years
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.3%
1/30 • 3 years
|
|
Nervous system disorders
Paresthesia
|
3.3%
1/30 • 3 years
|
|
Cardiac disorders
Pulmonary hypertension
|
3.3%
1/30 • 3 years
|
|
Endocrine disorders
Renal and urinary disorders - Other, specify
|
3.3%
1/30 • 3 years
|
|
Endocrine disorders
Renal colic
|
3.3%
1/30 • 3 years
|
|
Ear and labyrinth disorders
Sick sinus syndrome
|
3.3%
1/30 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.3%
1/30 • 3 years
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
3.3%
1/30 • 3 years
|
|
Endocrine disorders
Urine discoloration
|
3.3%
1/30 • 3 years
|
Additional Information
Shishir Maithel, MD
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Clinical Cancer Center
Phone: 312-908-5250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place