Phase 3 SCRT Chemo Targeted Immuno for High-Risk pMMR/MSS Rectal Adenocarcinoma
ClinicalTrials.gov Studies
Summary
NIH has registered Phase 3 clinical trial NCT07549399, a prospective randomized controlled study evaluating intensified neoadjuvant therapy for high-risk locally advanced pMMR/MSS rectal adenocarcinoma. The experimental arm combines short-course radiotherapy with mFOLFOX6 chemotherapy, plus either cetuximab (for RAS/BRAF wild-type) or bevacizumab (for RAS/BRAF mutant) plus a PD-1 monoclonal antibody, compared against radiotherapy plus mFOLFOX6 alone. The trial aims to establish superior neoadjuvant treatment strategies and provide high-level evidence-based medical evidence for this patient population.
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What changed
NCT07549399 is a newly registered Phase 3 randomized controlled clinical trial examining whether adding precise targeted therapy (cetuximab or bevacizumab based on RAS/BRAF status) and a PD-1 monoclonal antibody to short-course radiotherapy and mFOLFOX6 chemotherapy improves outcomes for high-risk locally advanced pMMR/MSS rectal adenocarcinoma patients. The study evaluates both efficacy and safety of this intensified regimen against the current standard of care.
For clinical investigators and oncology researchers, this trial represents a potential shift in neoadjuvant treatment paradigms for MSS rectal cancer. Sites with appropriate capabilities for radiotherapy, chemotherapy, immunotherapy administration, and surgical resection may consider participation. Patients with high-risk locally advanced rectal adenocarcinoma meeting trial criteria should discuss eligibility with their oncologists.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
Phase 3 NCT07549399 Kind: PHASE3 Apr 24, 2026
Abstract
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.
Conditions: Rectal Adenocarcinoma, High-Risk Cancer, MSS
Interventions: Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen, Cetuximab, Bevacizumab, Surgical resection
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