NCT06367270: PIPAC

The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies

Recruiting now Phase 2 Last updated 16 April 2024

What this trial tests

Phase 2 trial testing Pressured Intraperitoneal Aerosol Chemotherapy in Peritoneal Metastases in 60 participants. Currently enrolling.

Timeline

1 September 2023

Primary endpoint
31 August 2026

31 August 2027

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 September 2023
Primary completion	31 August 2026
Estimated completion	31 August 2027
Sites	1 location across Hong Kong

Drugs / interventions tested

• Pressured Intraperitoneal Aerosol Chemotherapy — full drug profile →

Conditions studied

• Peritoneal Metastases — all drugs for Peritoneal Metastases →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Peritoneal Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Peritoneal Metastasis in Patients with Pancreatic Ductal Adenocarcinoma.
   Wu G, Standring OJ, King DA, Gholami S, et al · · 2025 · cited 4× · PMID 39996904 · DOI 10.3390/curroncol32020103
2. Physiological Considerations and Delivery Strategies for Targeting Tumors Through Intraperitoneal Delivery.
   Jony MJH, Ranjbar S, Prajapati R, Eslami SM, et al · · 2025 · cited 2× · PMID 40855029 · DOI 10.1007/s11095-025-03917-0