Using aerosol chemotherapy to treat peritoneal metastatic adenocarcinoma
A Prospective, Multi-center, Single-arm Clinical Research Evaluating the Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastatic Adenocarcinoma
This study is testing a new way to deliver chemotherapy directly into the abdomen using a special spray for patients with advanced cancer that has spread to the lining of the belly.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06743867 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using a novel nebulized drug delivery system for patients with peritoneal metastatic adenocarcinoma originating from gastric, colorectal, appendiceal, or ovarian cancers. The study is a prospective, multi-center, single-arm trial that aims to assess various primary endpoints, including adverse events, postoperative pain, and quality of life. Customized treatment protocols will be established by a multidisciplinary committee, and patients will receive specific chemotherapeutic agents based on the origin of their cancer. The trial seeks to fill a gap in clinical data regarding the use of PIPAC in Asian populations, particularly among Chinese patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 75 with histopathologically verified peritoneal metastatic adenocarcinoma from specific cancer types and an ECOG performance status of 2 or less.
Not a fit: Patients with gastrointestinal obstruction, severe abdominal infections, or those who are fully reliant on parenteral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with peritoneal metastatic adenocarcinoma, potentially improving survival and quality of life.
How similar studies have performed: Other studies have shown promising results with PIPAC, indicating its potential as a viable treatment method, although this specific application in Asian populations is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yong Li, M.D., Ph.D.
- Email: liyong@gdph.org.cn
- Phone: +86 13822177479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.