UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

Summary

To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Irinotecan

Criteria

Inclusion Criteria:

1. Pathologically confirmed rectal adenocarcinoma

2. Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT.

3. Without distance metastases

4. A need for tumor withdrawal.

5. Aged 18-75 years old, regardless of gender.

6. ECOG score 0-2.

7. Detection of UGT1A1*6 and * 28 gene status.

8. Be able to comply with the plan during the study period.

9. Sign the inform consent

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ

3. If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.

4. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months

5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases

6. Subject blood routine and biochemical indicators do not meet the following criteria:

hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L

7. Anyone who is allergic to any research medication

8. DPD deficiency