SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer
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 Prospective, Multicenter Phase II Study
Sixth Affiliated Hospital, Sun Yat-sen University
49 participants
Apr 2, 2025
INTERVENTIONAL
Conditions
Summary
To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.
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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NCT06908031