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RECRUITING
NCT07549399
PHASE3

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

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

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

Interventions

RADIATION

Short-Course Radiotherapy

Patients undergo SCRT at a dose of 5Gy × 5 fractions

DRUG

PD-1 monoclonal antibody

Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.

DRUG

mFOLFOX6 regimen

Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.

DRUG

Cetuximab

Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.

DRUG

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)

PROCEDURE

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