Node-Sparing Short-Course Radiation with CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: a Randomized, Prospective, Multicenter Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Microsatellite Stable (MSS) Colon CancerLocally Advanced Colon Cancer
Interventions
DRUG

Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab

"Radiotherapy Protocol:~Short-course radiotherapy using three-dimensional conformal or intensity-modulated radiation therapy techniques. The radiation field will be limited to the tumor bed of the primary colon lesion, excluding surrounding draining lymph nodes and enlarged lymph nodes. The dose is fractionated as 5Gy per fraction, for a total of 25Gy over 5 fractions. Titanium clips will be placed on the proximal and distal ends of the colonic lesion via colonoscopy to guide radiation therapy positioning.~Chemotherapy Protocol (CAPOX Regimen):~1. Oxaliplatin: 130 mg/m², administered intravenously (ivgtt), on day 1 (d1).~2. Capecitabine: 1000 mg/m², orally (po), twice daily (bid), from day 1 to day 14 (d1-14).~Immunotherapy Protocol:~During preoperative treatment, Sintilimab (immune checkpoint inhibitor) will be administered concurrently with each chemotherapy cycle."

DRUG

CAPOX Chemotherapy

Participants will receive 4 cycles of CAPOX chemotherapy followed by radical total mesorectal excision surgery, and then 4 additional cycles of postoperative CAPOX chemotherapy.

Trial Locations (2)

310016

Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou

Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER

NCT06594692 - Node-Sparing Short-Course Radiation with CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: a Randomized, Prospective, Multicenter Study | Biotech Hunter | Biotech Hunter