💬In plain words
What the trial is, and whether it could suit you
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, Versi
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;
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:
1. Presenting symptoms of gastrointestinal obstruction;
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.
💊
What it tests
- Pressurized Intraperitoneal Aerosol Chemotherapy
Guangdong Provincial People's Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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