A Phase 2 interventional study of Tislelizumab + Capecitabine and Best supportive care in Metastatic Colorectal Cancer，NED, sponsored by Yanhong Deng. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Yanhong Deng · Phase 2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 52 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Yanhong Deng is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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
Best supportive care was the standard care in this setting.
Other: Best supportive care
Tislelizumab 200mg iv every 3 weeks, for 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.
Best supportive care
Disease-free survival
The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.
Time frame: 36 months
Overall survival
The time from NED to death from any cause
Time frame: 60 months
Adverse events
Side effect of both agents
Time frame: 60 months
Plan to share: No
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Yanhong Deng