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NOT YET RECRUITING
NCT06594692
PHASE2

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

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the use of node-sparing short-course radiotherapy combined with chemotherapy and Sintilimab, or chemotherapy alone, as neoadjuvant therapy for MSS-type locally advanced colon cancer. The goal is to explore the efficacy and safety of combining node-sparing short-course radiotherapy with chemotherapy and immunotherapy in the neoadjuvant setting for MSS-type locally advanced colon cancer, while also investigating the specific role of regional lymph nodes in tumor immunotherapy.

Official title: Node-sparing Modified Short-Course Radiation Combined With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer : A Randomized, Prospective, Multicenter, Open-label Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-10

Completion Date

2026-09-30

Last Updated

2024-09-19

Healthy Volunteers

No

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.

Locations (2)

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, China, China

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, China