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
Locations
1Sponsors and collaborators
Tao Zhang
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution