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
NCT07239466 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-04-23
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
- 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
-
1000mg/m2, bid, po, d1-14,q3w
- DRUG
-
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).
Sponsors & Collaborators
-
Tao Zhang
lead OTHER
Principal Investigators
-
Zhenyu Lin · Huazhong University of Science and Technology Tongji Medical College Union Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-01
Countries
- China
Study Locations
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