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

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия Short-course radiotherapy
  Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
• Препарат Capecitabine
  1000mg/m2, bid, po, d1-14,q3w
• Препарат Oxaliplatin
  130mg/m2, ivgtt, d1,q3w
• Процедура TME surgery
  The surgery was performed 1 week after the end of neoadjuvant therapy.
• Пищевая добавка β-hydroxybutyrate
  Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).

Первичные конечные точки

• complete response (CR) rate [Срок оценки: an expected average of 12 months]

Вторичные конечные точки (3)

• 3-year disease-Free Survival [Срок оценки: an expected average of 3 years]
• Overall Survival [Срок оценки: an expected average of 5 years]
• Adverse events (AEs) were graded according to the NCI CTCAE version 5·0 [Срок оценки: an expected average of 1.5 years]

Критерии участия

Критерии включения

• 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;
• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07239466 · Union-BHB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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