PIPAC combined with chemotherapy for patients with oligometastatic gastric cancer
Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer: a Randomized Multicenter Phase III Trial: PIPAC_VEROne
Run by Azienda Ospedaliera Universitaria Integrata Verona · NCT05303714 · Data updated 2026-11-12
This study is testing if a new way of giving chemotherapy directly into the abdomen, along with standard chemotherapy, can help people with a specific type of stomach cancer that has spread a little.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 1 site (Verona) |
| Status | Recruiting |
| Started | March 31, 2022 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2028 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT05303714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with primary resectable gastric cancer and positive peritoneal cytology or low burden peritoneal metastases confirmed by laparoscopy.
✕Probably not a fit
Patients with extraperitoneal metastases or those with a high peritoneal cancer index (PCI > 6) will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of PIPAC, a novel intraperitoneal chemotherapy technique, in combination with systemic chemotherapy for patients with oligometastatic gastric adenocarcinoma. Patients will be randomly assigned to receive either standard intravenous chemotherapy (FOLFOX) or FOLFOX plus PIPAC with cisplatin and doxorubicin. The study aims to evaluate the potential benefits of this multimodal approach in improving outcomes for patients with limited peritoneal metastasis. The trial is designed as a prospective, open-label, randomized multicenter phase III study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with oligometastatic gastric cancer.
How similar studies have gone: While PIPAC is a relatively novel approach, preliminary studies have shown promising results, indicating potential for success in this patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary resectable gastric cancer with positive peritoneal cytology and/or low burden peritoneal metastases (PCI ≤6) confirmed by laparoscopy * Signature of written informed consent * ECOG PS 0-1 Exclusion Criteria: * Extraperitoneal metastases * PCI \>6 * Gastro-esophageal junction tumor of esophageal relevance (Siewert I-II) * Previous allergic reactions to cisplatin or doxorubicin * Hemorrhagic or occlusive manifestation of the primary tumor with palliative surgery needed * ASA IV * Positivity for EBV, MSI and HER2 on diagnostic biopsies * Pregnancy and breastfeeding * Contraindication to any drug contained in the chemotherapy regimen * Hepatic impairment (AST/ALT\> 3 times normal values, ALT\>3 times normal values, Bilirubin\>1.5 normal values) * Ischemic/hemorrhagic stroke in the last 6 months * Acute myocardial infarction in the last 6 months * Moderate/severe heart failure (NYHA III-IV) * Leukopenia\< 2,000/μl * Thrombocytopenia \< 100,000/μl * Active hepatitis B or C * HIV infection * Creatinine clearance less than 30 ml/min
Where it's running
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AOUI Verona
Verona, Italy Recruiting
Study contacts
- Principal investigator: Francesco Casella — General and Upper GI Surgery, University of Verona
- Study coordinator: Francesco Casella
- Email: francesco.casella@aovr.veneto.it
- Phone: +390458123123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.