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RECRUITING
NCT06908031
PHASE2

SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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.

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 Prospective, Multicenter Phase II Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2025-04-02

Completion Date

2027-04-01

Last Updated

2025-05-14

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