Actively Recruiting
A Study Exploring Beta-Hydroxybutyrate Supplementation with Short-Course Radiotherapy Followed by Immunotherapy and CAPEOX Therapy in Locally Advanced Rectal Cancer
Led by Tao Zhang · Updated on 2026-04-23
25
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits of adding beta-hydroxybutyrate supplementation to a combination treatment for patients with locally advanced rectal cancer. This phase II clinical trial explores how this supplement works alongside short-course radiotherapy, followed by immunotherapy and CAPEOX chemotherapy, aiming to improve treatment outcomes. Participants will receive short-course radiotherapy delivering a total dose of 25 Gy over five consecutive days. Starting the first day of radiotherapy, they will take an oral supplement of beta-hydroxybutyrate (5 grams daily) for two weeks. One week after radiotherapy, patients will begin immunotherapy with a PD-1 monoclonal antibody given intravenously every three weeks for six cycles. Concurrently, they will receive CAPEOX chemotherapy consisting of oxaliplatin given intravenously once every three weeks and capecitabine taken orally twice daily for two weeks per cycle, totaling six cycles. Surgery will be performed one week after completing the neoadjuvant therapies. During the study, participants will be closely monitored for treatment response and safety. Researchers will assess the complete response rate around 12 months after treatment starts. They will also track disease-free survival over three years, overall survival over five years, and record any adverse events for about 1.5 years. Participants will undergo regular tests, including blood work and clinical evaluations, to monitor health and treatment effects throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their family members agree to participate and sign informed consent
- Age 18 to 75 years, male or female
- Histologically confirmed locally advanced rectal adenocarcinoma
- Tumor inferior margin 10 cm or less from the anal verge
- ECOG performance status score of 0-1
- No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery
- No contraindications for surgery
- Laboratory values within specified limits including adequate blood counts, liver and kidney function, and coagulation parameters
- Urinary protein less than 2+ or 24-hour urinary protein excretion below 1 g at baseline
You will not qualify if you...
- Patients with non-pMMR locally advanced rectal cancer
- Prior immunotherapy treatments including immune checkpoint inhibitors or immune cell therapy
- Any concurrent disease, condition, or history that may compromise safety, affect consent, compliance, or safety assessment of the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive short-course radiotherapy for 5 consecutive days and take oral β-hydroxybutyrate supplement daily starting from the first radiotherapy day for 2 weeks.
5 daily visits for radiotherapy and daily supplement intake
Duration - 18 weeks
Starting 1 week after radiotherapy, participants receive immunotherapy via intravenous infusion every 3 weeks for 6 cycles, combined with CAPEOX chemotherapy regimen over 18 weeks.
6 cycles with infusions and oral medication; visits every 3 weeks
Duration - 1 day
Participants undergo total mesorectal excision surgery 1 week after completing neoadjuvant therapy.
1 surgical visit (in-person)
Duration - Up to 1.5 years
Participants are monitored after surgery to assess recovery and safety outcomes.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Z
Zhenyu Lin, MD
T
Tao Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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