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

Condition(s) studied

Investigational drug(s) / intervention(s)

Irinotecan liposome II combination therapy regimen: In the A arm, the combined treatment with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg) is in the neoadjuvant therapy phase before TURBT surgery.

Irinotecan liposome II combination therapy regimen: In the B arm, the combined therapy with irinotecan liposome (intravenous injection, once every two weeks for 1 month, dose increasing regimen: 37.6 mg/m2 and 56.5mg/m2 ) and epirubicin (intravesical instillation, once a week for 1 month, 50 mg) is in the induction phase after TURBT surgery.

Study 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

Primary outcome measure(s)

• Bone marrow suppression (Grade four) — 4 weeks
  1. Absolute Neutrophil Count \< 0.5\*10\^9/L 2. Platelet \<25\*10\^9/L 3. leukocyte \<1.0\*10\^9/L

Trial sites (1)

More First Affiliated Hospital of Chongqing Medical University trials in China