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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

RecruitingPhase 2Ages 18 Years - 75 YearsAllUnion Hospital, Tongji Medical College, Huazhong …
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. 18-75 years 2. Men, or non-pregnant and non-lactating women 3. Pathological diagnosis as gastric malignant tumor 4. diagnosis of peritoneal metastasis \[peritoneal cancer index (PCI) ≤ 12 points\] by laparoscopic exploration 5. Normal major organ function: 1\) 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. 7\. 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. Exclusion Criteria: 1. Patients have other malignant tumors within the past 5 years. 2. 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. 3. Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases. 4. Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors. 5. Patients with epilepsy or other mental disorders. 6. Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases. 7. Pregnant or lactating women. 8. Patients with other distant metastasis
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What it tests

  • HIPEC
  • SOX
  • Immune Checkpoint Inhibitors
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Where

1 site
Wuhan Union Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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