Actively Recruiting
A Phase I, Open-Label Study of Irinotecan Liposomes Combined with Epirubicin in Adults with Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma After Anthracycline Treatment
Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-03-26
18
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new combined treatment using irinotecan liposomes (given by intravenous injection) and epirubicin (given by bladder instillation) for adults with non-muscle invasive bladder urothelial carcinoma that has returned after anthracycline treatment. This Phase I trial aims to find out the maximum safe dose and whether this combined approach can overcome resistance to anthracyclines. The study also explores the safety and biological effects of the treatment. Participants are assigned to one of two groups based on whether their recurrent tumor can be surgically removed by transurethral resection of bladder tumor (TURBT). In Arm A (unresectable tumors), patients receive irinotecan liposomes every two weeks for one month and epirubicin once a week for one month before evaluation by urologists. Those who respond may then undergo TURBT and further bladder therapy. Arm B (resectable tumors) involves TURBT surgery followed by immediate epirubicin instillation, then combined irinotecan liposomes and epirubicin weekly for one month, followed by monthly epirubicin for six months. Throughout the study, participants have regular clinic visits for physical exams and testing; visits occur every two weeks initially and then every three months for Arm B. They keep symptom diaries to track their experience. Researchers monitor bone marrow suppression, treatment safety, tumor response, recurrence-free survival, and biological markers from tumor tissue. The total study duration includes a four-week dose-limiting toxicity phase and longer follow-up for safety and tumor recurrence.
CONDITIONS
Brief Title
Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of non-muscle invasive urothelial carcinoma (cTa-cT1N0M0)
- Tumor recurrence after anthracycline treatment
- No prior systemic chemotherapy
- Measurable tumor according to Revised RECIST guidelines
- ECOG performance status 0 or 1
You will not qualify if you...
- Under 18 years of age
- Severe heart, brain, liver, or kidney disease
- Severe malnutrition
- Mental illness with lack of insight or inability to communicate clearly
- Presence of other malignant tumors
- Systemic infectious diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants in Arm A who cannot have their tumor excised will receive neoadjuvant therapy with irinotecan liposome intravenously once every two weeks for 1 month and epirubicin instilled once a week for 1 month before TURBT surgery.
2 visits (intravenous injection every 2 weeks) and 4 visits (intravesical instillation once a week)
Duration - 1 day
Participants in Arm B who have resectable tumors will undergo TURBT surgery with immediate intravesical instillation of epirubicin within 24 hours after surgery.
1 visit (in-person surgery and instillation)
Duration - 1 month
Participants in Arm B will receive combined irinotecan liposome intravenously once every two weeks for 1 month and epirubicin intravesically once a week for 1 month during the induction phase after surgery.
2 visits (intravenous injection every 2 weeks) and 4 visits (intravesical instillation once a week)
Duration - 6 months
Participants in Arm B will continue monthly intravesical instillation of epirubicin for the next 6 months after the induction phase.
Monthly visits for epirubicin instillation
Duration - Up to 6 months
Participants in both arms will visit the clinic every 2 weeks during the first month for checkups and tests. After the first month in Arm B, visits occur every 3 months for ongoing monitoring.
Biweekly visits during first month; then quarterly visits
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Chongqing Medica University
Chongqing, China, 400010
Actively Recruiting
Research Team
X
Xin Gou, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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