NCT07239466 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
| NCT ID | NCT07239466 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tao Zhang |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients or their family members agree to participate in the study and sign the informed consent form; 2. Age 18-75 years, male or female; 3. Histologically confirmed Locally Advanced rectal adenocarcinoma; 4. inferior margin ≤ 10 cm from the anal verge; 5. ECOG performance status score is 0-1; 6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc; 7. There was no operative contraindication; 8. 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 ti
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