PIPAC in Gastric Peritoneal Metastasis
NCT07517419 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-08
Summary
This is a pilot study aiming at evaluating the effects of PIPAC with Doxorubicin + Cisplastin on patients with PM of gastric cancer. All patients who are diagnosed with gastric cancer with peritoneal metastases in the Prince of Wales Hospital (PWH), HK will be screened for eligibility.
There are two aims for this study:
1. To evaluate safety and efficacy of the procedure together with postoperative outcomes and long term overall and progression free survival.
2. Aim at obtaining tissue samples for molecular analysis and for potential tissue organoids and biobank.
Conditions
- Gastric Cancer Peritoneal Metastases
Interventions
- DRUG
-
Cisplatin and Doxorubicin
Multiple PIAPC regimens have been studied. The most well studied PIPAC regimen include combination therapy of doxorubicin and cisplatin, oxaliplatin and paclitaxel. Low dose doxorubicin and cisplatin have been shown to be safe and well tolerated while achieving encouraging survival. The safety profile and tolerability of oxaliplatin have recently been studied in a Phase I dose finding escalation trial in human subjects. The optimal dose of IP oxaliplatin is yet to be determined. As for PIPAC with paclitaxel, studies are still limited to swine models. For the above reasons, low dose doxorubicin and cisplatin will be used in this feasibility study. New technology in genome, proteomics and findings microbiome gives rise to new method of personalised medicine for gastric cancer with PM and shed light the development of gastrointestinal malignancies, which will be studied well in this study.
Sponsors & Collaborators
-
Chinese University of Hong Kong
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-11
- Primary Completion
- 2031-02-28
- Completion
- 2031-02-28
Countries
- Hong Kong
Study Locations
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