Phase II Study of Beta-Hydroxybutyrate Supplementation with Short-Course Radiotherapy, Immunotherapy, and CAPEOX Chemotherapy in Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating the potential benefits of adding beta-hydroxybutyrate supplementation to a combination treatment for patients with locally advanced rectal cancer. This phase II clinical trial explores how this supplement works alongside short-course radiotherapy, followed by immunotherapy and CAPEOX chemotherapy, aiming to improve treatment outcomes. Participants will receive short-course radiotherapy delivering a total dose of 25 Gy over five consecutive days. Starting the first day of radiotherapy, they will take an oral supplement of beta-hydroxybutyrate 5 grams daily for two weeks. One week after radiotherapy, patients will begin immunotherapy with a PD-1 monoclonal antibody given intravenously every three weeks for six cycles. Concurrently, they will receive CAPEOX chemotherapy consisting of oxaliplatin given intravenously once every three weeks and capecitabine taken orally twice daily for two weeks per cycle, totaling six cycles. Surgery will be performed one week after completing the neoadjuvant therapies. During the study, participants will be closely monitored for treatment response and safety. Researchers will assess the complete response rate around 12 months after treatment starts. They will also track disease-free survival over three years, overall survival over five years, and record any adverse events for about 1.5 years. Participants will undergo regular tests, including blood work and clinical evaluations, to monitor health and treatment effects throughout the study.

A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer