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

Recruiting now · Phase 2

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT06685887

Run by

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

People needed

34

Starts

2025-02-15

Expected to finish

2027-12-01

Last updated by the study team

2025-04-11

Who can join

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

You may qualify if…

• 18-75 years
• Men, or non-pregnant and non-lactating women
• Pathological diagnosis as gastric malignant tumor
• diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
• Normal major organ function:
• HB ≥ 90 g/L； ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL<1.5ULN; ALT, AST <2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
• Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.

You may not qualify if…

• Patients have other malignant tumors within the past 5 years.
• Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled corticosteroids or systemic steroids from consideration.
• Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
• Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
• Patients with epilepsy or other mental disorders.
• Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
• Pregnant or lactating women.
• Patients with other distant metastasis

Where it is running

• Wuhan Union Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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