A Phase IbIII Study Comparing Neoadjuvant QL1706 to Standard Treatment in Adults With Untreated MSI-High or dMMR Resectable Colon Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of neoadjuvant QL1706 in people with untreated T4N0 or Stage III resectable, microsatellite instability highdefective mismatch repair MSI-HdMMR colon cancer. This study focuses on participants with colon adenocarcinoma that can be surgically removed and aims to compare QL1706 with the current standard care treatments. The trial is an open-label, randomized Phase IbIII study sponsored by Qilu Pharmaceutical Co., Ltd. Participants in the Phase IbII part will receive QL1706 before surgery. After surgery, participants are randomly assigned to receive either standard care chemotherapy with CAPEOXCapecitabine or undergo expectant observation. The study includes treatment and follow-up phases to monitor outcomes and safety over time. During the study, participants will undergo assessments including surgery and pathological examination to measure the complete response rate one month after surgery. Researchers will track event-free survival, overall survival, tumor removal success, and treatment side effects for up to approximately 5 years. Participants will be closely monitored for adverse events, immune-related reactions, and treatment tolerability throughout the study period.

A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer