Phase III Trial Comparing Short-Course Versus Long-Course Radiotherapy Followed by Immunotherapy and Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are investigating treatments for locally advanced rectal cancer in this national, multicenter, randomized, placebo-controlled Phase III clinical trial. The study aims to evaluate whether combining immunotherapy with total neoadjuvant therapy TNT offers better benefits than long-course radiotherapy followed by TNT alone. It also compares the effectiveness and side effects of different radiotherapy types when combined with immunotherapy under TNT. Participants are assigned to one of three groups one receives short-course radiotherapy SCRT followed by immunotherapy and chemotherapy another receives long-course radiotherapy LCRT with concurrent chemotherapy plus immunotherapy and chemotherapy and the third group receives LCRT with concurrent chemotherapy followed by TNT chemotherapy and a placebo instead of immunotherapy. Immunotherapy or placebo is given via intravenous infusion every three weeks for six cycles. After neoadjuvant therapy, patients may undergo surgery or opt for a watch-and-wait approach if they achieve complete remission. During the study, participants undergo dynamic monitoring including MRI and blood tests to track tumor response and minimal residual disease, especially for tumors close to the anal verge. Researchers assess outcomes such as event-free survival over three years, complete response rates, overall survival, and treatment side effects using standardized criteria. The trial includes follow-up visits and safety evaluations over several years to monitor long-term effects and treatment results.

A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer