drugset / Trial / NCT07549399

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

NCT07549399

Phase 3 Recruiting 204 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.

Timeline

Start
2026-05-20
Primary completion
2029-04-30
Completion
2029-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody
Subject Cetuximab Monoclonal antibody

Indications