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

Launched by FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with non-muscle invasive bladder cancer that has come back after previous chemotherapy treatment with anthracyclines. The researchers want to find out if a combination of two drugs, irinotecan liposomes (given as an injection) and epirubicin (given directly into the bladder), can help patients whose cancer has not responded to earlier treatments. They will also look at how safe this new treatment is and how it works in the body. Patients will be divided into two groups: one will receive the treatment before a procedure to remove the tumor, while the other will get the treatment afterward.

To be eligible for this trial, participants should be adults aged 18 and older with specific types of bladder cancer that have come back after anthracycline treatment. They should not have any severe health issues or other cancers. During the study, participants will visit the hospital regularly for check-ups and will need to keep a diary of their symptoms. This is an important opportunity to explore a potential new treatment option for bladder cancer that has not responded to previous therapies.

Gender

ALL

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