NCT07239466

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

A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.

Conditions

• Rectal Cancer
• Radiotherapy
• Immunotherapy
• Chemotherapy

Interventions

Type	Name	Description
RADIATION	Short-course radiotherapy	Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
DRUG	Capecitabine	1000mg/m2, bid, po, d1-14,q3w
DRUG	Oxaliplatin	130mg/m2, ivgtt, d1,q3w
PROCEDURE	TME surgery	The surgery was performed 1 week after the end of neoadjuvant therapy.
DIETARY_SUPPLEMENT	β-hydroxybutyrate	Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: China