Neoadjuvant Tislelizumab with Chemotherapy for Locally Advanced MSS Rectal Cancer Phase II Single-Arm Study Evaluating Treatment Effects and Surgery Outcomes

What this Trial Is About

This research aims to understand the effects of using neoadjuvant Tislelizumab combined with chemotherapy in treating locally advanced microsatellite stable MSS rectal cancer. The standard care for this condition involves chemoradiotherapy followed by surgery, which reduces recurrence risk but can cause side effects affecting quality of life. This study explores a different approach by combining immunotherapy with chemotherapy to potentially improve treatment outcomes. Participants will receive two or four cycles of treatment combining Tislelizumab, Oxaliplatin, and Capecitabine before undergoing total mesorectal excision TME surgery. Oxaliplatin is given intravenously every three weeks, Capecitabine is taken orally twice daily for two weeks, and Tislelizumab is administered every three weeks. Following these treatments, patients will have surgery to remove the tumor. Throughout the study, participants will be monitored with enhanced CT scans, MRI, and ultrasound to evaluate their response before surgery. Researchers will assess the primary outcome by examining the rate of complete tumor response in surgical specimens within seven days after surgery. Secondary outcomes include clinical response rates, survival rates over three years, adverse event rates, surgical complications, and local recurrence. Participants will be followed for up to three years after treatment to track these outcomes and overall safety.

The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer