NCT04889768

HIPEC Combined With Camrelizumab, Paclitaxel and S-1 for Conversion Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There is no currently available treatment for peritoneal metastasis of gastric cancer. Hyperthermic intraperitoneal chemotherapy (HIPEC) can not only maintain the high concentration of drugs in the abdominal cavity, but also improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. In recent years, immunotherapy has made great progress in the treatment of gastric cancer. We want to explore the hyperthermic intraperitoneal chemotherapy (HIPEC) combined with Camrelizumab (SHR-1210) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Detailed description

To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, anti-PD-1 antibody Camrelizumab (SHR-1210), intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis, so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Conditions

• Gastric Cancer, HIPEC, Anti-PD-1 Antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery

Interventions

Type	Name	Description
DRUG	HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery	1. HIPEC: Taxol (Paclitaxel Injection) 75 mg/m2, d1, d3 within 72 hours after surgical exploration; oral chemotherapy:S-1: 80mg/m2, twice daily for d1-d14, and then suspend for one week; Intravenous drip anti-PD-1 antibody Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks. 2. Chemotherapy and PD-1 treatment (4 cycles) : Taxol 150mg/m2,d1; S-1: 80-120mg/m2, twice daily for two weeks, and then suspend for one week; Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks. 3. Surgery: Secondary surgical exploration: if PCI less than 20, then assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). For inoperable patients, continue to use this program for treatment. 4. After the surgery, HIPEC for two cycles, anti-PD-1 antibody Camrelizumab (SHR-1210) for 4 cycles, and PS chemotherapy for 4 cycles.

Timeline

• Start date: 2021-07-31
• Primary completion: 2023-07-31
• Completion: 2025-07-31
• First posted: 2021-05-17
• Last updated: 2021-05-17

Locations

1 site across 1 country: China