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NCT Number: NCT06766266

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Chongqing Medica University

Chongqing, 400010, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan liposome II combination therapy regimen

Drug

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.

Primary outcomes

  1. Bone marrow suppression (Grade four)

    Time frame: 4 weeks

    • Absolute Neutrophil Count < 0.5*10^9/L
    • Platelet <25*10^9/L
    • leukocyte <1.0*10^9/L

Secondary outcomes

  1. Safety and adverse events

    Time frame: 2 months

    The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.

  2. Objective remission rate (Arm A available)

    Time frame: 4 weeks

    The proportion of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) after treatment was calculated according to the recognized response evaluation criteria (such as New response evaluation criteria in solid tumours: Revised RECIST guideline , version 1.1).

    CR: All tumor target lesions disappeared and no new lesions appeared. PR: The sum of maximum diameter of tumor target lesions decreased by ≥30%; SD: The sum of the maximum diameter of tumor target lesions did not shrink to PR, or increase to PD; PD: The sum of the maximum diameters of tumor target lesions increases at least ≥20%, or new lesions appear.

  3. Recurrence-free survival (Arm B available)

    Time frame: 3-6 months

    The time from TURBT surgery to recurrence or the end of follow-up.

  4. BLM Lactylation of tumor tissues

    Time frame: 4 weeks

    The BLM lactylation of tumor tissue

  5. The levels of DNA double-strand break and homologous recombination repair in tumor tissues

    Time frame: 4 weeks

    The levels of DNA double-strand break and homologous recombination repair in tumor tissues are detected

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Gou, Professor

CONTACT

[email protected]

0086+13650518875

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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