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
| NCT ID | NCT07239466 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tao Zhang |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Zhenyu Lin
PRINCIPAL INVESTIGATOR
Huazhong University of Science and Technology Tongji Medical College Union Hospital
Frequently Asked Questions
Who can join the NCT07239466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07239466 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07239466 currently recruiting?
Yes, NCT07239466 is actively recruiting participants. Contact the research team at whxhlzy@hust.edu.cn for enrollment information.
Where is the NCT07239466 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07239466 clinical trial?
NCT07239466 is sponsored by Tao Zhang. The principal investigator is Zhenyu Lin at Huazhong University of Science and Technology Tongji Medical College Union Hospital. The trial plans to enroll 25 participants.
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