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

NCT07304271 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-12-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Magnus Nilsson

    lead OTHER

Principal Investigators

  • Magnus Nilsson, MD, Professor · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304271 on ClinicalTrials.gov