NCT05148767 UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
| NCT ID | NCT05148767 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Rectal Cancer Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 606 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 606 participants in total. It began in 2022-01-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ji Zhu, MD
PRINCIPAL INVESTIGATOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT05148767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05148767 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05148767 currently recruiting?
Yes, NCT05148767 is actively recruiting participants. Contact the research team at leo.zhu@126.com for enrollment information.
Where is the NCT05148767 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05148767 clinical trial?
NCT05148767 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Ji Zhu, MD at Zhejiang Cancer Hospital. The trial plans to enroll 606 participants.
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