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Phase I Study of Chemotherapy and Immune Checkpoint Inhibitors Combined with Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer with Peritoneal Metastasis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-04-11
34
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with gastric cancer that has spread to the peritoneum, an advanced disease stage with poor prognosis. This phase II clinical trial aims to study the effect of combining hyperthermic intraperitoneal chemotherapy HIPEC with systemic chemotherapy and immune checkpoint inhibitors on the rate of complete tumor removal R0 resection. The study also examines overall survival, progression-free survival, tumor burden, and treatment side effects in these patients. The treatment involves HIPEC using oxaliplatin heated to 43C for 60 minutes following laparoscopic surgery, combined with systemic chemotherapy SOX regimen including oxaliplatin and S-1 and immune checkpoint inhibitor therapy with tislelizumab given every three weeks. Participants will receive this combined regimen to assess its safety and potential to improve outcomes for peritoneal metastasis from gastric cancer. Participants will undergo laparoscopic exploration to confirm eligibility, followed by treatment and regular follow-up for up to three years. Researchers will monitor tumor removal success, survival rates at 1, 2, and 3 years, progression-free survival, and adverse reactions. The study includes detailed assessments of organ function, performance status, and adverse events throughout the treatment and observation period to evaluate safety and effectiveness.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Male, or female who is not pregnant or breastfeeding
- Pathological diagnosis of gastric malignant tumor
- Diagnosis of peritoneal metastasis with a peritoneal cancer index (PCI) of 12 or less confirmed by laparoscopic exploration
- Normal major organ function including hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5×10^9/L, platelets ≥ 125×10^9/L, total bilirubin < 1.5 times upper limit of normal, ALT and AST < 2.5 times upper limit of normal, creatinine ≤ 1.25 times upper limit of normal, albumin ≥ 30 g/L
- No prior radiation therapy, chemotherapy, targeted therapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Voluntary agreement and ability to cooperate with study data collection
You will not qualify if you...
- Other malignant tumors within the past 5 years
- Use of immunosuppressants within 30 days before starting tislelizumab, except nasal sprays and physiological doses of inhaled or systemic steroids
- History of ongoing or prior autoimmune diseases
- Allergies to oxaliplatin, S-1, related chemotherapy drugs, or immune checkpoint inhibitors
- Epilepsy or other mental disorders
- Severe heart, lung, or vascular diseases preventing surgery
- Pregnant or breastfeeding women
- Presence of other distant metastases
Research Team
K
Kaixiong Tao, PhD
Y
Yuping Yin, PhD
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