Combining irinotecan liposomes and epirubicin for bladder cancer treatment after anthracyclines failure
Official title: A Phase I, Open-Label Clinical Study of Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-Muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
Run by First Affiliated Hospital of Chongqing Medical University · NCT06766266 · Data updated 2026-11-12
This study is testing a new treatment that combines two drugs, irinotecan liposomes and epirubicin, to see if it can help people with bladder cancer who didn't get better with previous therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | April 24, 2025 |
| Study ends | December 24, 2025 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT06766266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with non-muscle invasive urothelial carcinoma who have experienced tumor recurrence after anthracycline treatment and have not undergone systemic chemotherapy.
✕Probably not a fit
Patients under 18 years old, those with severe comorbid conditions, or individuals with mental illness may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of a new treatment combining irinotecan liposomes administered intravenously and epirubicin given intravesically for patients with recurrent non-muscle invasive bladder urothelial carcinoma who have previously failed anthracycline therapy. The study will assess dose-limiting toxicities, the potential to reverse drug resistance, and the biological mechanisms involved in the treatment's effects. Participants will be divided into two arms to receive the treatment regimen and monitor their responses and side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with bladder cancer who have not responded to previous anthracycline treatments.
How similar studies have gone: While this approach is novel, similar studies exploring combination therapies for bladder cancer have shown promise in addressing treatment resistance.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * cTa-cT1N0M0 patients with non-muscle invasive urothelial carcinoma * Tumor recurrence occurred after anthracyclines treatment * Systemic chemotherapy had not been used * Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline * ECOG (ZPS, 5-point scale) 0-1 Exclusion Criteria: * Age less than 18 years * Patients with severe cardiac, cerebral, hepatic, or renal disease * Severely malnourished patients * Patients with mental illness and those without insight and unable to express exactly * Combined with malignant tumors of other organs * Systemic infectious diseases
Where it's running
-
The First Affiliated Hospital of Chongqing Medica University
Chongqing, China Recruiting
Study contacts
- Study coordinator: Xin Gou, Professor
- Email: cymnk@163.com
- Phone: 0086+13650518875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.