Spots Global Cancer Trial Database for Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Official Title: Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Study ID: NCT05360277
Conditions
Study Description
Brief Summary: Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.
Detailed Description: This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED. Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gastrointestinal Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Contact Details
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