PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer

Recruiting now · Phase 3

Conditions studied: Oligometastatic Gastric Adenocarcinoma

In brief

Peritoneal Carcinomatosis is the most frequent site of metastases observed in patients with gastric cancer. Current standard treatment for these patients is palliative systemic chemotherapy, but the prognosis is very poor. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients with limited peritoneal involvement. Indeed, among patients with Peritoneal Carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. PIPAC is a recent technique of intraperitoneal chemotherapy that can be used in combination with systemic chemotherapy with promising results for patients with PM from gastric cancer. The role of PIPAC in multimodal treatment path for oligometastatic gastric cancer should be investigated in clinical trials. PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial with two arms that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with Gastric Cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (PCI ≤ 6). Patients will be randomized into two arms: arm A (control) treated with the current standard that is systemic chemotherapy only and Arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy (1 PIPAC every 2 systemic chemotherapy cycles). Primary endpoint is the Secondary Resectability Rate. Secondary endpoints are: Overall Survival, Progression Free Survival, Disease Free Survival, histological response assessed both on primary tumor and peritoneal lesions, Quality of Life, complication rate (CTCAE v5), incremental cost-effectiveness ratios (ICER).

Key facts

Study ID

NCT05303714

Run by

Azienda Ospedaliera Universitaria Integrata Verona

People needed

98

Starts

2022-03-31

Expected to finish

2028-09-30

Last updated by the study team

2025-02-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• AOUI Verona — Verona, Italy (enrolling)

Full record on ClinicalTrials.gov

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