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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

ConditionsRectal CancerRadiotherapyImmunotherapyChemotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTao Zhang

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Short-course radiotherapy

    Radiation

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

  • Capecitabine

    Drug

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

  • Oxaliplatin

    Drug

    130mg/m2, ivgtt, d1,q3w

  • TME surgery

    Procedure/Surgery

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

  • β-hydroxybutyrate

    Dietary supplement

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 5 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tao Zhang

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov
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