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

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

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

Treatments tested in this trial

  • Short-course radiotherapy
  • Capecitabine
  • Oxaliplatin
  • TME surgery
  • β-hydroxybutyrate

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tao Zhang

Lead sponsor

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

Sponsor institution