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HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
Sponsor: Sichuan University
Summary
The prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Hyperthermic intraperitoneal chemotherapy (HIPEC) represents a novel treatment option, which maintains the high concentration of drugs in the abdominal cavity, and improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma with peritoneal metastasis.
Official title: The Efficacy and Safety of Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis: A Prospective, Single-arm, Phase II Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2024-02-20
Completion Date
2027-06-30
Last Updated
2024-01-19
Healthy Volunteers
No
Conditions
Interventions
S-1, Oxaliplatin sintilimab HIPEC
1. Exploratory laparoscopy or laparotomy 2. SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA\<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA \< 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. 3. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, 4. In the second and third cycles, HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated according to the patient's condition. 5. Another 3-cycle SOX regimen of systemic chemotherapy. 6. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.