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
HIPEC: HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.
SOX: 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
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
R0 resection rate — 1 year The proportion of patients who achieved R0 resection
Trial sites (1)
Facility
City
Region
Status
Wuhan Union Hospital
Wuhan
Hubei
Recruiting
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.