Combining chemotherapy and immune therapy with heated chemotherapy for gastric cancer with peritoneal spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-center, phase II investigation that evaluates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with systemic chemotherapy and immune checkpoint inhibitors in patients suffering from gastric cancer with peritoneal metastasis. The study aims to determine the impact of this treatment regimen on the rate of complete tumor resection (R0), overall survival, progression-free survival, and the incidence of adverse reactions. By utilizing a comprehensive treatment protocol, the trial seeks to enhance the prognosis for patients facing this advanced stage of gastric cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Wuhan Union Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Kaixiong Tao, PhD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Kaixiong Tao, PhD
• Email: taokaixiong@hust.edu.cn
• Phone: 13507155452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.