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Brief Title: S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma
Official Title: Perioperative SOX Plus Sintilimab Compared With Perioperative SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: an Open-label, Phase 2 Randomised Controlled Trial
Study ID: NCT04989985
Brief Summary: For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.
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. Unfortunately, over 70% of gastric cancer patients in China were diagnosed in advanced stage, and more than 80% of adenocarcinoma of esophagogastric junction(AEG) were advanced stage. Locally advanced AEG (cT3-4aN+M0) could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. As proved, Neoadjuvant chemotherapy can downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival in AEG patients. However, the therapeutic effects remain unsatisfactory. PD-1 antibody has demonstrated its efficacy in metastatic AEG and has been proved to be effective in neoadjuvant setting in lung cancer and melanoma. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sinitilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for lymphoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sinitilimab in combination with perioperative chemotherapy(SOX: oxaliplatin plus S-1) in locally advanced AEG.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The sixth affiliated hospital of Sun Yat-sen University, GuangZhou, Guangdong, China
Name: Jun-Sheng Peng, Dr
Affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR