Two-cycle PD-1 Blockade with Tislelizumab Compared to Standard Care as Adjuvant Treatment for High-risk Stage II dMMRMSI-H Colorectal Cancer

What this Trial Is About

Researchers are evaluating the use of two cycles of PD-1 blockade with Tislelizumab as adjuvant therapy compared to standard of care in patients with high-risk stage-II dMMRMSI-H colorectal cancer. This phase III open-label trial aims to see if this approach can improve disease-free survival and overall survival, based on evidence that neoadjuvant immunotherapy reduces tumor recurrence and that short-course treatment may balance benefits with fewer side effects. Participants are randomly assigned to one of two groups. The experimental group receives Tislelizumab 200mg intravenously on day 1 and day 22, with or without adjuvant chemotherapy, while the control group receives standard of care, which may include surveillance alone or chemotherapy options like Capecitabine or CapeOxFOLFOX. Routine follow-up visits occur every 3 months for the first 3 years and every 6 months during years 4 and 5. Throughout the study, participants undergo evaluations to measure disease-free survival over 3 years and overall survival over 5 years, along with monitoring adverse events up to 30 days after treatment ends. The study involves regular clinical assessments, imaging tests, and safety monitoring to track treatment effects. Enrollment is planned for 180 patients and follow-up extends over several years to assess long-term outcomes.

Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer