The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
NCT ID: NCT06743867
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2024-12-11
2026-09-30
Brief Summary
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The primary objectives of this study are to assess the safety and efficacy of PIPAC with the novel NDDS in the treatment of PMA. Primary endpoints include adverse events (AEs) and serious AEs, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidences of device defects, postoperative pain scores evaluated using the Visual Analogue Scale / Score (VAS), and quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). Secondary endpoints include the intra-abdominal peritoneal cancer index (PCI), peritoneal regression grading score (PRGS), objective response rate (including partial response (PR) and complete response (CR)), improvement in ascites, conversion rate (patients proceeding to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following initial PIPAC treatments), progression-free survival (PFS), and overall survival (OS).
Detailed Description
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The NDDS novel consists of a central computer with an operating system, a high-pressure peristaltic pump, an emergency stops switch, a liquid level sensor, and an integrated unit featuring a 10-mm spray nozzle, an anti-high-pressure infusion tube, and a puncture head. PIPAC is conducted under a standard 12 mmHg pneumoperitoneum. Doxorubicin and cisplatin are administered for patients with PMA originating from gastric or ovarian cancers, whereas oxaliplatin is utilized for PMA resulting from colorectal or appendiceal cancers. Customized treatment protocols, encompassing drug dosages, are established by a multidisciplinary peritoneal carcinomatosis committee before the administration of PIPAC.
Qualified patients will undergo three cycles of PIPAC in conjunction with concurrent systemic chemotherapy (e.g., XELOX or FOLFOX). The interval between successive PIPAC procedures is 4 to 6 weeks, with an additional interval of one to two weeks between PIPAC and systemic chemotherapy. The anticipated therapy duration for each patient is three months, during which the primary and secondary endpoints will be assessed.
This research will take place in 25 domestic medical centers, aiming for a sample size of 30 cases.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)
Drug: Pressurized Intraperitoneal Aerosol Chemotherapy
Pressurized Intraperitoneal Aerosol Chemotherapy
The comprehensive therapeutic strategy will be modified based on the integrated 2- or 3-week systemic chemotherapies. In the interim, a total of three PIPAC procedures will be conducted for all qualifying patients.
1. PIPAC combined with 2-week systemic chemotherapies:
PIPAC therapy will occur every four weeks, while systemic chemotherapies will be administered during the first and third weeks following the initial and second PIPAC procedures respectively.
2. PIPAC combined with 3-week systemic chemotherapies:
(1) Scheme 1: PIPAC therapy will occur every 6 weeks, with systemic chemotherapies administered during the 1st and 4th weeks following the first and second PIPAC procedures, respectively.
(2) Scheme 2: PIPAC therapy will occur every 6 weeks, while systemic chemotherapies will be administered in the 2nd and 5th weeks following the initial and second PIPAC procedures, respectively.
Interventions
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Pressurized Intraperitoneal Aerosol Chemotherapy
The comprehensive therapeutic strategy will be modified based on the integrated 2- or 3-week systemic chemotherapies. In the interim, a total of three PIPAC procedures will be conducted for all qualifying patients.
1. PIPAC combined with 2-week systemic chemotherapies:
PIPAC therapy will occur every four weeks, while systemic chemotherapies will be administered during the first and third weeks following the initial and second PIPAC procedures respectively.
2. PIPAC combined with 3-week systemic chemotherapies:
(1) Scheme 1: PIPAC therapy will occur every 6 weeks, with systemic chemotherapies administered during the 1st and 4th weeks following the first and second PIPAC procedures, respectively.
(2) Scheme 2: PIPAC therapy will occur every 6 weeks, while systemic chemotherapies will be administered in the 2nd and 5th weeks following the initial and second PIPAC procedures, respectively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Applicable to individuals of either sex, aged between 18 and 75 years;
3. Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;
4. Absence of other concurrent malignancies;
5. Without contraindications for laparoscopic surgery;
6. Laboratory testing: blood routine examination: neutrophil count ≥ 1.5× 10\^9/L, platelet count ≥ 80 × 10\^9/L, hemoglobin ≥ 80g/L ; blood biochemistry: serum total bilirubin ≤ 1.5 ×ULN, Alanine transaminase and aspartate aminotransferase ≤ 2.5 ×ULN, serum creatinine ≤ 1.5 ×ULN;
7. Life expectancy \> 6 months;
8. Informed consent understood and signed.
Exclusion Criteria
2. Fully reliant on parenteral nutrition;
3. Exhibiting decompensated ascites;
4. Suffering from severe abdominal infection (indications of peritonitis);
5. Characterized by extensive adhesions in the abdominal cavity;
6. Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures;
7. With portal vein thrombosis;
8. Concurrently, individuals with significant or unmanaged medical conditions or infections (including atrial fibrillation, angina, cardiac dysfunction, ejection fraction \< 50%, refractory hypertension etc.);
9. Previous chemotherapeutic drugs allergy;
10. Severe cardiopulmonary, hepatonephric, hematologic, and metal diseases, or drug abuse;
11. Pregnancy or lactating women;
12. Engage in additional clinical trials within three months preceding recruitment;
13. Other conditions: patients are inappropriately included as determined by researchers.
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Third Central Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Henan Cancer Hospital
OTHER_GOV
Tongji Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Southern Medical University, China
OTHER
Affiliated Hospital of Qinghai University
OTHER
Ruijin Hospital
OTHER
Shenzhen Second People's Hospital
OTHER
West China Hospital
OTHER
Tianjin Nankai Hospital
OTHER
Wannan Medical College Yijishan Hospital
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Changzhi People's Hospital
OTHER
First Hospital of China Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Sun Yat-sen University
OTHER
Fujian Medical University Union Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yong Li, M.D., Ph.D.
Role: primary
Other Identifiers
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PIPAC-HOPE-01
Identifier Type: -
Identifier Source: org_study_id