Yanhong Deng
Yanhong Deng
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.
Metastatic Colorectal Cancer,NED
Tislelizumab + Capecitabine
Best supportive care
Phase 2
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.
Study Type : | Interventional |
Estimated Enrollment : | 52 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease |
Actual Study Start Date : | August 22, 2023 |
Estimated Primary Completion Date : | February 28, 2025 |
Estimated Study Completion Date : | November 30, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Tislelizumab + Capecitabine Tislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy. |
Drug: Tislelizumab + Capecitabine |
Active Comparator: Best supportive care Best supportive care was the standard care in this setting. |
Other: Best supportive care |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655