Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
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.
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