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RecruitingNCT07239466Updated Apr 23, 2026

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 Phase 2 interventional study of Short-course radiotherapy and Capecitabine in Rectal Cancer, Radiotherapy and Immunotherapy, sponsored by Tao Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Tao Zhang · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rectal Cancer
  • Radiotherapy
  • Immunotherapy
  • Chemotherapy

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    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 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

  • RadiationShort-course radiotherapy

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

  • DrugCapecitabine

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

  • DrugOxaliplatin

    130mg/m2, ivgtt, d1,q3w

  • ProcedureTME surgery

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

  • Dietary supplementβ-hydroxybutyrate

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

05

What researchers measure

Primary outcomes

  1. complete response (CR) rate

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

    Time frame: an expected average of 12 months

Secondary outcomes

  1. 3-year disease-Free Survival

    The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first

    Time frame: an expected average of 3 years

  2. Overall Survival

    The time from the date of randomization to the death caused by any cause

    Time frame: an expected average of 5 years

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

    Adverse events and surgical safety

    Time frame: an expected average of 1.5 years

06

Study locations

1 of 1 sites recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07239466
Lead sponsor
Tao Zhang
Responsible party
Tao Zhang (MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Sponsor-investigator
First posted
Nov 20, 2025
Start date
Jan 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Zhenyu Lin, MD
Contact
whxhlzy@hust.edu.cn
027-83262683
Tao Zhang, MD
Contact
whxhlzy@hust.edu.cn
Zhenyu Lin
principal investigator · Huazhong University of Science and Technology Tongji Medical College Union Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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