Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2029

Conditions
Rectal Cancer
Interventions
RADIATION

Lymph-node-sparing short-course radiotherapy

Three-dimensional conformal or intensity-modulated radiotherapy targeting only the primary tumor bed (no regional lymph nodes), delivering a total dose of 25 Gy in 5 Gy fractions over five consecutive days.

DRUG

Capecitabine

Oral capecitabine 1,000 mg/m² administered twice daily on Days 1-14 of each 21-day cycle, for a total of four cycles.

DRUG

PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection)

Intravenous PD-1/CTLA-4 bispecific monoclonal antibody at 5 mg/kg every 3 weeks for four cycles, starting on Day 8 after completion of radiotherapy.

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER