Clinical trial · Interventional
PIPAC in Gastric Peritoneal Metastasis
Pressurized IntraPeritoneal Aerosol Chemotherapy With Cisplatin and Doxorubicin (PIPAC) in Gastric Peritoneal Metastasis: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin and Doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- 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.
- interventionNames
- Drug: Cisplatin and Doxorubicin
Primary outcomes (1)
- measure
- Mortality
- timeFrame
- From recruitment up to five years / death
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients age \>= 18, \<= 80 years old 2. Performance status (WHO) \<=2 3. Histologically evidenced synchronous PM of gastric adenocarcinoma cancer 4. Peritoneal Cancer Index (PCI) score \> 8, or \<=8 and patient not fit for cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) 5. Patients with isolated ovarian metastasis could be included 6. White blood cells \>3.5000/mm3; neutrophils \> 1.500/mm3; platelets \>100,000/mm3 7. Creatinine \<1.5mg/dL and creatinine clearance \>60ml/min and serum total bilirubin \<2mg/dL 8. Ability to give written consent prior to commencement of treatment Exclusion Criteria: 1. Extraperitoneal metastases including liver metastases and malignant pleural effusion. The presence of suspicious retroperitoneal lymph nodes is not an exclusion criterium. 2. Patients with adenocarcinoma of Siewart I 3. Bowel obstruction, not tolerating oral diet 4. HER2+++ tumor with indicated for Trastuzumab therapy 5. Any laparotomy during 3 months before inclusion. (Laparoscopy is not an exclusion criterium) 6. Contraindicated to any drug contained in the chemotherapy regimen 7. Concomitant intraperitoneal chemotherapy, immunotherapy or target therapy 8. Active infectious (bacterial, viral) disease. Elevated CRP with no identified focus is not an exclusion criterium 9. Pregnancy or breastfeeding
References
Publications (0)
Data not yet available