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 | Recruiting Phase 2 DMC

• 1 other identifier: Union-BHB
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Chemotherapy; Rectal Cancer; Radiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• complete response (CR) rate

  Defined as pathological complete response (pCR) + Clinical complete response (cCR)

  an expected average of 12 months

Secondary Outcomes (3)

• 3-year disease-Free Survival

  an expected average of 3 years

• Overall Survival

  an expected average of 5 years

• Adverse events (AEs) were graded according to the NCI CTCAE version 5·0

  an expected average of 1.5 years

Study Arms (1)

experimental group

EXPERIMENTAL

Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). β-hydroxybutyrate: Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks). Immunotherapy (PD-1 monoclonal antibody): 200 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase.

Radiation: Short-course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Procedure: TME surgery; Dietary Supplement: β-hydroxybutyrate

Interventions

Short-course radiotherapy RADIATION

Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.

experimental group

Capecitabine DRUG

1000mg/m2, bid, po, d1-14,q3w

experimental group

Oxaliplatin DRUG

130mg/m2, ivgtt, d1,q3w

experimental group

TME surgery PROCEDURE

The surgery was performed 1 week after the end of neoadjuvant therapy.

experimental group

β-hydroxybutyrate DIETARY_SUPPLEMENT

Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their family members agree to participate in the study and sign the informed consent form;
• Age 18-75 years, male or female;
• Histologically confirmed Locally Advanced rectal adenocarcinoma;
• inferior margin ≤ 10 cm from the anal verge;
• ECOG performance status score is 0-1;
• Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;
• There was no operative contraindication;
• Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
• Urinary protein \< 2+ or 24-hour urinary protein excretion \< 1 g at baseline.

You may not qualify if:

• Patients with non-pMMR LARC；
• Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;
• Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).

Sponsors & Collaborators

• Tao Zhang: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Zhenyu Lin

  Huazhong University of Science and Technology Tongji Medical College Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Lin, MD

CONTACT

027-83262683; whxhlzy@hust.edu.cn

Tao Zhang, MD

CONTACT

whxhlzy@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-11

Locations

CN (1)