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Spots Global Cancer Trial Database for Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer

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Trial Identification

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

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

Study ID: NCT04367025

Conditions

Gastric Cancer

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chinese PLA General Hospital, Beijing, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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