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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 31, 2021

Status verified

Mar 2021

Primary completion

Jul 31, 2023

Completion

Jul 31, 2025

Study Design

Enrollment

46 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental: HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery
  1. surgical exploration, if PCI\<20, then we perform this study. 2. 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. 3. 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. 4. 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. 5. After the surgery, HIPEC for two cycles, anti-PD-1 antibody Camrelizumab (SHR-1210) for 4 cycles, and PS chemotherapy for 4 cycles.

Primary Outcome Measure

R0 resection [ Time Frame: 3 months ]