PIPAC in Gastric Peritoneal Metastasis

NCT07517419 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: 2020.677
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate safety and efficacy of the procedure together with postoperative outcomes and long term overall and progression free survival.
2. 2.Aim at obtaining tissue samples for molecular analysis and for potential tissue organoids and biobank.

Conditions

Gastric Cancer Peritoneal Metastases

Keywords

PIPAC; Gastric peritoneal metastasis

Outcome Measures

Primary Outcomes (1)

• Mortality

  We aim to recruit 30 patients or until 5 years has been reached. The patients will then be followed-up to up to 5 years or death. A first report regarding the safety and feasibility would be generated after 15 patients complete the 6-month follow-up.

  From recruitment up to five years / death

Secondary Outcomes (12)

• Clinical Outcomes - Safety, tolerability, and postoperative complications

  Baseline, postoperatively 2 weeks after each PIPAC, then every 3 months till patient died/until 5 years after recruitment

• Clinical Outcomes - PCI

  Baseline, postoperatively 2 weeks after each PIPAC, then every 3 months till patient died/until 5 years after recruitment

• Clinical Outcomes - Karnofsky Score

  Baseline, postoperatively 2 weeks after each PIPAC, then every 3 months till patient died/until 5 years after recruitment

• Clinical Outcomes - PRGS

  Baseline, postoperatively 2 weeks after each PIPAC, then every 3 months till patient died/until 5 years after recruitment

• Clinical Outcomes - Time point of peritoneal metastasis

  Baseline, postoperatively 2 weeks after each PIPAC, then every 3 months till patient died/until 5 years after recruitment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Patients will first be obtained inform consent. Then they will be screened for eligibility, and an explorative laparoscopy will be performed, if eligibility met. Patients will be arranged for the PIPAC with cisplatin and doxorubicin, if further PCI score criteria is met. The study aims to perform PIPAC 3 times, once every 6-8 weeks. Tissue sampling as stated earlier, will be performed. Depending on patient's condition and disease responsiveness upon completion of chemotherapy, a staging laparoscopy may be performed at 3 months (e.g.: 1 month after the third PIPAC). After PIPAC, patients will remain as inpatient for 2 days. They will be evaluated with clinical examination daily. The patients will be seen postoperatively 2 weeks after each PIPAC, then every 3 months till patient succumbs.

Drug: Cisplatin and Doxorubicin

Interventions

Cisplatin and Doxorubicin DRUG

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.

Also known as: PIPAC with cisplatin and doxorubicin

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age \>= 18, \<= 80 years old
• Performance status (WHO) \<=2
• Histologically evidenced synchronous PM of gastric adenocarcinoma cancer
• Peritoneal Cancer Index (PCI) score \> 8, or \<=8 and patient not fit for cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CRS + HIPEC)
• Patients with isolated ovarian metastasis could be included
• White blood cells \>3.5000/mm3; neutrophils \> 1.500/mm3; platelets \>100,000/mm3
• Creatinine \<1.5mg/dL and creatinine clearance \>60ml/min and serum total bilirubin \<2mg/dL
• Ability to give written consent prior to commencement of treatment

You may not qualify if:

• Patients with adenocarcinoma of Siewart I
• Bowel obstruction, not tolerating oral diet
• HER2+++ tumor with indicated for Trastuzumab therapy
• Contraindicated to any drug contained in the chemotherapy regimen
• Concomitant intraperitoneal chemotherapy, immunotherapy or target therapy
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Shatin, HK

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Cisplatin; Doxorubicin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: PIPAC treatment with Doxorubicin and Cisplatin on patients with PM of gastric cancer

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 8, 2026
• Study Start: October 11, 2021
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)