Clinical Trial

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

Study acronym: CRITⅡ
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-02
Trial Details
NCT Number NCT07549399
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions Rectal Adenocarcinoma, High-Risk Cancer, MSS
Enrollment 204 participants
Start Date 2026-05-20
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-01