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

PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 2, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2027

Conditions
Rectal AdenocarcinomaHigh-Risk CancerMSS
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.

Trial Locations (1)

510065

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER