Actively Recruiting
The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
Led by Guangdong Provincial People's Hospital · Updated on 2024-12-20
30
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
T
Tianjin Third Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is a prospective, multi-center, single-arm clinical trial aimed at assessing the standard pressurized intraperitoneal aerosol chemotherapy (PIPAC) utilizing a novel nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancer. 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).
CONDITIONS
Official Title
The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed peritoneal metastatic adenocarcinoma from gastric, colorectal, appendiceal, or ovarian cancer
- Age between 18 and 75 years, any sex
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- No other concurrent cancers
- Eligible for laparoscopic surgery without contraindications
- Laboratory values: neutrophils ≥ 1.5×10^9/L, platelets ≥ 80×10^9/L, hemoglobin ≥ 80 g/L
- Liver function: total bilirubin ≤ 1.5× upper limit normal, ALT and AST ≤ 2.5× upper limit normal
- Kidney function: serum creatinine ≤ 1.5× upper limit normal
- Life expectancy greater than 6 months
- Signed informed consent
You will not qualify if you...
- Symptoms of gastrointestinal obstruction
- Fully dependent on parenteral nutrition
- Decompensated ascites
- Severe abdominal infection such as peritonitis
- Extensive abdominal adhesions
- Undergoing cytoreductive surgery or gastrointestinal resection and reconstruction
- Presence of portal vein thrombosis
- Serious or uncontrolled medical conditions or infections including atrial fibrillation, angina, cardiac dysfunction with ejection fraction less than 50%, refractory hypertension
- Allergy to chemotherapy drugs
- Severe heart, lung, liver, kidney, blood diseases, or drug abuse
- Pregnancy or lactation
- Participation in other clinical trials within 3 months before enrollment
- Any other conditions judged inappropriate by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
Y
Yong Li, M.D., Ph.D.
CONTACT
L
Liming Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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