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

NCT ID: NCT07239466

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-01

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

Rectal Cancer; Radiotherapy; Immunotherapy; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

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 2 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 2 cycles during the neoadjuvant phase.

Group Type: EXPERIMENTAL

β-hydroxybutyrate

Intervention Type: DIETARY_SUPPLEMENT

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

Short-course radiotherapy

Intervention Type: RADIATION

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

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

130mg/m2, ivgtt, d1,q3w

TME surgery

Intervention Type: PROCEDURE

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

Interventions

β-hydroxybutyrate

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

Intervention Type: DIETARY_SUPPLEMENT

Short-course radiotherapy

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

Intervention Type: RADIATION

Capecitabine

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

Intervention Type: DRUG

Oxaliplatin

130mg/m2, ivgtt, d1,q3w

Intervention Type: DRUG

TME surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients or their family members agree to participate in the study and sign the informed consent form;

2. Age 18-75 years, male or female;

3. Histologically confirmed Locally Advanced rectal adenocarcinoma;

4. inferior margin ≤ 10 cm from the anal verge;

5. ECOG performance status score is 0-1;

6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;

7. There was no operative contraindication;

8. 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;

9. Urinary protein < 2+ or 24-hour urinary protein excretion < 1 g at baseline.

Exclusion Criteria

1. Patients with non-pMMR LARC；

2. 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;

3. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhenyu Lin

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology Tongji Medical College Union Hospital

Locations

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

Wuhan, Hubei, China

Countries

China

Central Contacts

Zhenyu Lin, MD

Role: CONTACT

whxhlzy@hust.edu.cn

027-83262683

Tao Zhang, MD

Role: CONTACT

whxhlzy@hust.edu.cn

Facility Contacts

Tao Zhang, MD

Role: primary

1277577866@qq.com

027-83262683

Other Identifiers

Union-BHB

Identifier Type: -

Identifier Source: org_study_id