Rectal CancerPhase 2NCT07239466
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 study testing Short-course radiotherapy, Capecitabine and Oxaliplatin in people with Rectal Cancer and Radiotherapy, run by Tao Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Radiotherapy, Immunotherapy
- What is being tested?
- Short-course radiotherapy, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tao Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tao Zhang, MD, 027-83262683, 1277577866@qq.com
About this study
Official title: A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer
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
- Being tested
- Short-course radiotherapy, Capecitabine, Oxaliplatin, TME surgery, β-hydroxybutyrate
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
CapecitabineDrug
1000mg/m2, bid, po, d1-14,q3w
OxaliplatinDrug
130mg/m2, ivgtt, d1,q3w
TME surgeryProcedure or surgery
The surgery was performed 1 week after the end of neoadjuvant therapy.
β-hydroxybutyrateDietary supplement
Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Short-course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Procedure: TME surgery; Dietary Supplement: β-hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Measured: an expected average of 12 months
Secondary outcomes (3)
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
Measured: an expected average of 3 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zhenyu Lin, Principal investigator, Huazhong University of Science and Technology Tongji Medical College Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239466
- Sponsor's protocol ID
- Union-BHB
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07239466
- Acronym / sponsor ID
- Union-BHB
- Conditions
- Rectal Cancer, Radiotherapy, Immunotherapy, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: Short-course radiotherapy, Drug: Capecitabine, Drug: Oxaliplatin, Procedure: TME surgery, Dietary Supplement: β-hydroxybutyrateRadiotherapy (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-course radiotherapyEligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy. | Radiation | experimental group |
| Capecitabine1000mg/m2, bid, po, d1-14,q3w | Drug | experimental group |
| Oxaliplatin130mg/m2, ivgtt, d1,q3w | Drug | experimental group |
| TME surgeryThe surgery was performed 1 week after the end of neoadjuvant therapy. | Procedure or surgery | experimental group |
| β-hydroxybutyrateOral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks). | Dietary supplement | experimental group |
Primary outcome
complete response (CR) rate
Time frame: an expected average of 12 months
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
3 secondary outcomes
3-year disease-Free Survival
Time frame: an expected average of 3 years
Overall Survival
Time frame: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Zhang, MD contact
Zhenyu Lin principal investigator
Huazhong University of Science and Technology Tongji Medical College Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short-course radiotherapy, Capecitabine and Oxaliplatin in people with Rectal Cancer and Radiotherapy, run by Tao Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Lin, MD (027-83262683, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) rate (time frame: an expected average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.