SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial
Sixth Affiliated Hospital, Sun Yat-sen University
204 participants
May 20, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Patients undergo SCRT at a dose of 5Gy × 5 fractions
Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.
Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.
Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.
Patients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)
Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.
Locations(1)
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NCT07549399