Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2031

Conditions
Rectal CancerNeoadjuvant TherapiesImmune Checkpoint TherapyRadiotherapy
Interventions
COMBINATION_PRODUCT

Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor

Patients will receive node-sparing modified short-course radiotherapy, followed by six cycles of CAPOX chemotherapy combined with a PD-1 inhibitor. After neoadjuvant treatment, patients will either undergo total mesorectal excision (TME) surgery or enter a watch-and-wait strategy based on clinical assessment.

COMBINATION_PRODUCT

Conventional Radiotherapy plus Chemotherapy and PD-1 inhibitor

Patients will receive conventional-target short-course radiotherapy, followed by six cycles of CAPOX chemotherapy. After neoadjuvant treatment, patients will either undergo TME surgery or enter a watch-and-wait strategy based on clinical assessment.

Trial Locations (1)

510655

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER