RecruitingPhase 2NCT06908031

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

49 participants

Start Date

Apr 2, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment approach for high-risk rectal cancer — short-course radiation followed by chemotherapy plus an immunotherapy drug and a targeted therapy drug — before surgery, to see if this improves outcomes compared to standard care. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rectal cancer (a specific molecular subtype called pMMR/MSS) confirmed by biopsy - Your tumor is within 10 cm of the anal opening - Your cancer is locally advanced with specific high-risk features on imaging - Your cancer has not spread to distant organs - You have not had any prior cancer treatments (chemotherapy, radiation, immunotherapy, or targeted therapy) - You are in good overall health **You may NOT be eligible if...** - You have already received cancer treatment - Your cancer has spread to other parts of the body - You have a different molecular type of rectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONShort-Course Radiotherapy

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

DRUGPD-1 monoclonal antibody

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

DRUGmFOLFOX6 regimen

Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.

DRUGCetuximab

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

DRUGBevacizumab

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)

PROCEDURESurgical 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

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NCT06908031


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