NCT06367270 The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
| NCT ID | NCT06367270 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Peritoneal Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-09-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity.
Eligibility 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
Contact & Investigator
Ian WONG, Dr.
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06367270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritoneal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06367270 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06367270 currently recruiting?
Yes, NCT06367270 is actively recruiting participants. Contact the research team at iyhwong@hku.hk for enrollment information.
Where is the NCT06367270 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06367270 clinical trial?
NCT06367270 is sponsored by The University of Hong Kong. The principal investigator is Ian WONG, Dr. at The University of Hong Kong. The trial plans to enroll 60 participants.