Clinical trial NCT06766266: Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a double cohort study, the two cohorts are incomparable. If the recurrent tumor can't be excised by transurethral resection of bladder tumor (TURBT), the participant will enter the A arm, and if the recurrent tumor can be excised by TURBT, the participant will enter the B arm.
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Bone marrow suppression (Grade four)
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety and adverse events
timeFrame: 2 months
measure: Objective remission rate (Arm A available)
timeFrame: 4 weeks
measure: Recurrence-free survival (Arm B available)
timeFrame: 3-6 months
measure: BLM Lactylation of tumor tissues
timeFrame: 4 weeks
measure: The levels of DNA double-strand break and homologous recombination repair in tumor tissues
timeFrame: 4 weeks
Other outcomes:
Locations:
city: ChongQing
country: China
facility: The First Affiliated Hospital of Chongqing Medica University
Study officials:
affiliation: cymnk@163.com
name: Xin Gou, Professor
role: STUDY_CHAIR
References: