RecruitingPhase 2NCT06685887

A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

34 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding heated chemotherapy directly into the abdomen (called HIPEC) during surgery, combined with systemic chemotherapy and immunotherapy, improves outcomes for patients with gastric (stomach) cancer that has spread to the lining of the abdominal cavity (peritoneal metastasis). **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with stomach cancer that has spread to the peritoneum (abdominal lining), confirmed by laparoscopy - The spread is limited (peritoneal cancer index of 12 or less) - You have not yet received chemotherapy, radiation, or targeted therapy - You are physically functional (ECOG 0–1) - Your blood counts and organ function are in an adequate range **You may NOT be eligible if...** - You have another active cancer from the past 5 years - You have an active autoimmune disease - You are allergic to any of the study medications - You have epilepsy or significant mental health conditions - You are pregnant or breastfeeding - You have cancer that has spread beyond the peritoneum to other distant sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHIPEC

HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.

DRUGSOX

Oxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA \<1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w

DRUGImmune Checkpoint Inhibitors

Tislelizumab, 200 mg, q3w


Locations(1)

Wuhan Union Hospital

Wuhan, Hubei, China

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NCT06685887


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