NCT07304271

Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis

Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Magnus Nilsson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.

Conditions

• Gastric Cancer Peritoneal Metastases

Interventions

Type	Name	Description
DRUG	Intraperitoneal Paclitaxel	Intraperitoneally administered Paclitaxel
DRUG	Standard systemic therapy	Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting

Timeline

• Start date: 2025-11-05
• Primary completion: 2031-01-31
• Completion: 2031-01-31
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

5 sites across 2 countries: Italy, Sweden