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Brief Title: A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer
Official Title: The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial
Study ID: NCT04351867
Brief Summary: This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.
Detailed Description: In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Henan Cancer Hospital, Zhengzhou, Henan, China
Name: Ning Li, PhD
Affiliation: Henan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Suxia Luo, PhD
Affiliation: Henan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR