SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Locally Advanced Rectal Cancer (LARC)
Interventions
DRUG

Experimental

The experimental group will receive neoadjuvant short-course radiotherapy (dose 25Gy/5f), followed by CAPEOX+Iparomlimab and Tuvonralimab (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w; Iparomlimab and Tuvonralimab 5mg/kg iv d1, q3w) for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year.

DRUG

Control

The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w) for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles.

Trial Locations (1)

310006

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER