Phase III Study of Short-Course Radiotherapy with mFOLFOX6, PD-1 Antibody, and Targeted Drugs Based on RASBRAF Status in High-Risk Rectal Adenocarcinoma

What this Trial Is About

Researchers are studying a new treatment approach for patients with high-risk, locally advanced rectal adenocarcinoma that is pMMRMSS type. This phase III randomized controlled trial compares an intensified treatment combining short-course radiotherapy, mFOLFOX6 chemotherapy, targeted therapy based on RASBRAF status, and a PD-1 monoclonal antibody with a regimen of short-course radiotherapy followed by mFOLFOX6 chemotherapy alone. The goal is to find a better neoadjuvant treatment to improve pathological response and long-term outcomes for this high-risk group. Participants are assigned to one of two groups. The experimental group receives short-course radiotherapy combined with four cycles of mFOLFOX6 chemotherapy, PD-1 monoclonal antibody, and targeted therapy cetuximab for RASBRAF wild-type and bevacizumab for mutant. The control group receives short-course radiotherapy combined with four cycles of mFOLFOX6 chemotherapy only. Radiotherapy is given as 5Gy in 5 fractions. Surgery is scheduled 8 to 10 weeks after radiotherapy, with either local excision or total mesorectal excision depending on MRI results. Adjuvant chemotherapy is decided by the treating physician. During the study, participants undergo treatment cycles and surgery with monitoring of safety and response. Researchers assess outcomes including 3-year disease-free survival, pathological complete response rate, overall survival, distant metastasis-free survival, relapse-free survival, surgical resection quality, and treatment-related toxicities. The study includes regular evaluations like imaging and lab tests to track progress and side effects, with participant involvement lasting through treatment and follow-up periods up to three years.

SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC