UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

NCT05148767 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang Cancer Hospital

Phase

Phase 4

Started

2022-01-01

Last updated

2021-12-08

Condition(s) studied

Rectal Cancer Stage III

Investigational drug(s) / intervention(s)

Neoadjuvant chemoradiotherapy based on irinotecan

Neoadjuvant chemoradiotherapy based on irinotecan: Patients with locally advanced rectal cancer treated with irinotecan-based chemoradiotherapy were enrolled in this study. The dose of irinotecan is determined by the genotype of UGT1A1.Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2 (UGT1A1\*28 and \*6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1\*28 and \*6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Complete remission rate — 3 months after neoadjuvant chemoradiotherapy
The tumor disappeared completely and the tumor markers remained normal for at least 4 weeks.
Locally recurrence rate — Within 5 years after the end of treatment
The proportion of recurrent rectal tumors in the total population after the complete regression of rectal tumors
DFS — Within 5 years after the end of treatment
The time from complete regression of the tumor after neoadjuvant therapy or radical resection to the first recurrence or death
OS — Within 5 years after the end of treatment
The time from enrolled in the study to death caused by any cause
Toxicity effect — Within 5 years after the end of treatment
Any adverse reactions caused by neoadjuvant chemoradiotherapy or surgery

Trial sites (1)

Facility	City	Region	Status
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05148767 on ClinicalTrials.gov ↗ ← All trials in China