NCT06213519

HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer with peritoneal metastasis, patients will receive SOX regimen chemotherapy combined with sintilimab, once every three weeks. In the first cycle, HIPEC will be administrated, and HIPEC or intraperitoneal chemotherapy will be administrated in the second to third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy will be administrated. After the end of 6 cycles, patients will receive maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.

Conditions

• Peritoneal Metastases
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-02-20
• Primary completion: 2027-05-30
• Completion: 2027-06-30
• First posted: 2024-01-19
• Last updated: 2024-01-19