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

NCT06367270 — Phase 2, Recruiting, 60 participants, The University of Hong Kong

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT06367270, acronym PIPAC
Status	Recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	The University of Hong Kong (Other)
Conditions	Peritoneal Metastases
Interventions	Pressured Intraperitoneal Aerosol Chemotherapy (Drug)
Dates	start 2023-09-01, primary completion 2026-08-31 (estimated), completion 2027-08-31 (estimated), first posted 2024-04-16, last updated 2026-04-30
Locations	1 site in Hong Kong

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
PIPAC	Experimental	Drug: Pressured Intraperitoneal Aerosol Chemotherapy

Pressured Intraperitoneal Aerosol Chemotherapy (Drug), also known as PIPAC: PIPAC cycles will be scheduled every 6-8 weeks and 2 weeks after the last systemic chemotherapy administration. The bidirectional program for the combination of intraperitoneal and systemic chemotherapy is designed as follows: systemic chemotherapy followed by PIPAC two weeks later, followed by a one-week interval, and then systemic chemotherapy once again until three PIPAC cycles have been completed. Up to a one-week delay in returning to systemic chemotherapy after PIPAC and vice versa were considered acceptable. Systemic drug choice was based on previous chemotherapy exposure and the medical oncologists' decision. The study ends after the 3rd cycle of PIPAC.

+Outcome measures

Primary outcomes

Clinical benefit rate (CBR) [At the end of Cycle 3 (each cycle is 6 to 8 weeks)]: Clinical benefit rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST).

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Queen Mary Hospital	Hong Kong	Hong Kong	Recruiting

+Investigators

Ian WONG, Dr., Principal investigator, The University of Hong Kong

My Notes

Public

To Read Reading Read