Combining irinotecan liposomes and epirubicin for bladder cancer treatment after anthracyclines failure
A Phase I, Open-Label Clinical Study of Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-Muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
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 |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT06766266 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old, those with severe comorbid conditions, or individuals with mental illness may not benefit from this study.
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 performed: While this approach is novel, similar studies exploring combination therapies for bladder cancer have shown promise in addressing treatment resistance.
Eligibility criteria
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 this trial is running
Chongqing
- 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
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.