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SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-05-20
Completion Date
2029-04-30
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
Short-Course Radiotherapy
Patients undergo SCRT at a dose of 5Gy × 5 fractions
PD-1 monoclonal antibody
Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.
mFOLFOX6 regimen
Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.
Cetuximab
Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.
Bevacizumab
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)
Surgical resection
Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.
Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China