Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irinotecan liposome II combination therapy regimen, Irinotecan liposome II combination therapy regimen.
- Who it may be relevant to
- Registry conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
The goal of this clinical trial is to learn the dose-limiting toxicity of the new combined treatment with irinotecan liposomes (intravenous injection) and epirubicin (intravesical instillation) in anthracyclines treatment-failed non-muscle invasive bladder cancer adults. It will also learn if the combined treatment works to treat these patients. Additionally, the safety and biological mechanisms of the combined treatment will also be explored. The main questions it aims to answer are: * Does the combined treatment of irinotecan liposomes and epirubicin reverse anthracyclines resistance of participants? * What medical problems do participants have after taking the combined treatment of irinotecan liposomes and epirubicin? * What biological mechanisms underlie the effect of irinotecan liposomes on anthracyclines resistance? Participants will be classified into Arm A and Arm B. * Arm A: Participants will receive an intravenous injection of irinotecan liposomes once every two weeks for one month, along with intravesical instillation of epirubicin once a week for one month. Patients will be evaluated by two professional urologists; those with a complete response or partial response will undergo transurethral resection of bladder tumor (TURBT) and intravesical therapy. Patients with stable or progressive disease will receive subsequent treatment at the investigator's discretion. Participants are required to visit the hospital for physical examination every two weeks. * Arm B: In the first month after TURBT surgery, participants will receive intravenous injection of irinotecan liposomes once every two weeks for one month, and intravesical instillation of epirubicin once a week for one month, followed by once a month for six months. Participants are required to visit the clinic for physical examination once every two weeks in the first month, and once every three months after that. * Keep a diary of their symptoms during the study period.
Interventions
- Drug Irinotecan liposome II combination therapy regimen
In the A arm, the combined treatment with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg) is in the neoadjuvant therapy phase before TURBT surgery. - Drug Irinotecan liposome II combination therapy regimen
In the B arm, the combined therapy with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2 ) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg) is in the induction phase after TURBT surgery.
Primary outcome measures
- Bone marrow suppression (Grade four) [Time frame: 4 weeks]
Secondary outcome measures (5)
- Safety and adverse events [Time frame: 2 months]
- Objective remission rate (Arm A available) [Time frame: 4 weeks]
- Recurrence-free survival (Arm B available) [Time frame: 3-6 months]
- BLM Lactylation of tumor tissues [Time frame: 4 weeks]
- The levels of DNA double-strand break and homologous recombination repair in tumor tissues [Time frame: 4 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medica University — Chongqing
Publications
- Li X, Zhang C, Mei Y, Zhong W, Fan W, Liu L, Feng Z, Bai X, Liu C, Xiao M, He W, Lin T, Gou X. Irinotecan alleviates chemoresistance to anthracyclines through the inhibition of AARS1-mediated BLM lactylation and homologous recombination repair. Signal Transduct Target Ther. 2025 Jul 10;10(1):214. doi: 10.1038/s41392-025-02302-y. PMID 40634292
Identifiers
NCT: NCT06766266 · 2024-549-02