Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06766266

Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment

Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-03-26

18

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with non-muscle invasive urothelial carcinoma classified as cTa-cT1N0M0
  • Tumor recurrence after anthracyclines treatment
  • No prior systemic chemotherapy used
  • Tumor measurable by New response evaluation criteria in solid tumours (Revised RECIST guideline)
  • ECOG performance status 0 or 1 (on a 5-point scale)
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Severe cardiac, cerebral, hepatic, or renal disease
  • Severe malnutrition
  • Mental illness or inability to express oneself clearly
  • Presence of other malignant tumors in different organs
  • Systemic infectious diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chongqing Medica University

Chongqing, China, 400010

Actively Recruiting

Loading map...

Research Team

X

Xin Gou, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here