Using Pressurized Aerosol Chemotherapy for Peritoneal Cancer
The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
This study is testing a new way to deliver chemotherapy directly into the abdomen to see if it helps people with advanced colorectal, gastric, or pancreatic cancers that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06367270 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in treating patients with peritoneal metastases from unresectable colorectal, gastric, and pancreatic cancers. The study involves administering PIPAC with oxaliplatin, doxorubicin, and cisplatin, aiming to assess its therapeutic efficacy and safety in a single-arm, open-label format. Participants will receive three cycles of PIPAC along with systemic chemotherapy, with treatments repeated every 6-8 weeks. The trial focuses on patients who have not previously undergone PIPAC and are treatment-naïve or have progressed on first-line systemic therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable colorectal, gastric, or pancreatic cancers and peritoneal metastases who have not received prior PIPAC treatment.
Not a fit: Patients with extra-peritoneal metastases, significant renal or liver impairment, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new palliative treatment option for patients with difficult-to-treat peritoneal metastases.
How similar studies have performed: Previous phase I studies have shown PIPAC to be a safe and feasible treatment, but evidence in Asian populations is limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years of old; 2. WHO performance of status 0-1; 3. Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma; 4. Treatment naïve patients as first-line treatment; 5. Progression on or intolerance to first-line systemic chemotherapy as second-line treatment; 6. No symptoms of gastrointestinal obstruction; 7. No contraindications for the planned systemic therapy or laparoscopy; 8. No previous PIPAC/IP/HIPEC; 9. No other concurrent malignancies or any other malignancy within 6 months prior to enrolment; 10. Able to give written informed consent. Exclusion Criteria: 1. A history of allergic reaction to platinum containing compounds or doxorubicin; 2. Pregnant or breastfeeding; 3. Any extra-peritoneal metastases; 4. Renal impairment, defined as GFR less than 40 mL/min; 5. Impaired liver function defined as bilirubin over 1.5 × UNL; 6. Inadequate haematological function * Leucocyte \< 3.00 × 109/L * Absolute neutrophil counts \< 1.50 × 109/L * Platelet \< 100 × 109/L
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Ian WONG, Dr. — The University of Hong Kong
- Study coordinator: Ian WONG, Dr.
- Email: iyhwong@hku.hk
- Phone: +852 2255 4774
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.