UGT1A1-guided irinotecan therapy for advanced rectal cancer
Neoadjuvant Chemoradiation With Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer: A Real-Word Multi-center Study
PHASE4 · Zhejiang Cancer Hospital · NCT05148767
This study is testing if adjusting the dose of irinotecan based on a specific gene can help people with advanced rectal cancer do better with their treatment before surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 606 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05148767 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with pathologically confirmed rectal adenocarcinoma at clinical stage T3-4, who are eligible for neoadjuvant chemoradiotherapy.
Not a fit: Patients with distant metastases, pregnant or breastfeeding women, or those with uncontrolled severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with locally advanced rectal cancer.
How similar studies have performed: Previous studies have shown promising results with UGT1A1-guided irinotecan therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer Stage III, locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, irinotecan