NCT04367025

Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer

Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody (Camrelizumabin) the Locally Advanced Adenocarcinoma of Stomach or Gastroesophageal Junction

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab（SHR-1210） in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma. This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.

Detailed description

Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China. Surgery is the only possible way to cure gastric cancer, however, over 80-90% of gastric cancer patients in China are in advanced stage. Locally advanced gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma .This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab: 200mg,iv drip for 1h,d1,q3w
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;
DRUG	S1	S-1:40\~60mg Bid, d1\~14, q3w;

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-05-01
• Completion: 2023-05-01
• First posted: 2020-04-29
• Last updated: 2020-04-29

Locations

1 site across 1 country: China