UGT1A1-guided irinotecan therapy for advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of irinotecan therapy guided by UGT1A1 gene status in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiotherapy. The aim is to enhance the clinical efficacy of standard treatment, which typically includes chemoradiotherapy followed by surgery. By tailoring irinotecan dosing based on genetic factors, the study seeks to improve patient outcomes, including rates of pathological complete remission. Previous research has indicated a potential for increased dose intensity of irinotecan to improve treatment results.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ji Zhu, MD — Zhejiang Cancer Hospital
• Study coordinator: Ji Zhu, MD
• Email: leo.zhu@126.com
• Phone: 571-88128142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.