NCT06766266 Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
| NCT ID | NCT06766266 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | Non-Muscle Invasive Bladder Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2025-04-24 |
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 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-01-10 with a primary completion date of 2025-04-24.
⚠ 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
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.
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
Contact & Investigator
Xin Gou, Professor
STUDY CHAIR
cymnk@163.com
Frequently Asked Questions
Who can join the NCT06766266 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Muscle Invasive Bladder Urothelial Carcinoma. 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 NCT06766266 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06766266 currently recruiting?
Yes, NCT06766266 is actively recruiting participants. Contact the research team at cymnk@163.com for enrollment information.
Where is the NCT06766266 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06766266 clinical trial?
NCT06766266 is sponsored by First Affiliated Hospital of Chongqing Medical University. The principal investigator is Xin Gou, Professor at cymnk@163.com. The trial plans to enroll 18 participants.