UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Plain-language summary

This study evaluates irinotecan-based neoadjuvant (pre-surgery) chemoradiotherapy tailored to a patient's UGT1A1 gene status in people with locally advanced rectal cancer. It is enrolling patients aged 18-75 with pathologically confirmed rectal adenocarcinoma who have had UGT1A1 gene testing. The study is in Phase 4 and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Recruiting

Sponsor

Zhejiang Cancer Hospital

Intervention

Neoadjuvant chemoradiotherapy based on irinotecan

Start date

1/1/2022

Estimated completion

12/30/2026

Countries

China

Related genes

Locations

• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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