Non-Muscle Invasive Bladder Urothelial CarcinomaPhase 1NCT06766266
Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
A Phase 1 study testing Irinotecan liposome II combination therapy regimen in people with Non-Muscle Invasive Bladder Urothelial Carcinoma, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Urothelial Carcinoma
- What is being tested?
- Irinotecan liposome II combination therapy regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 24 Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medica University
Chongqing, 400010
About this study
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
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.
Read more
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.
- Being tested
- Irinotecan liposome II combination therapy regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome II combination therapy regimenDrug
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 regimenDrug
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 group | Role | What they receive |
|---|---|---|
| Arm A: TURBT unresectable | Experimental | If the recurrent tumor can't be excised by TURBT, participants will be assigned to this arm. Participants in this arm will complete the neoadjuvant 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), and the therapeutic effect was evaluated by pelvic enhanced MRI and cystoscopy. Judged by two urologists with senior professional title, patients with complete response and partial response were treated with TURBT and intravesical therapy. Patients with stable disease or progressive disease received subsequent therapy at the investigator's discretion. Participants will visit the clinic once every 2 weeks for checkups and tests. Receives: Drug: Irinotecan liposome II combination therapy regimen |
| Arm B: TURBT resectable | Experimental | If the recurrent tumor can be excised by TURBT, participants will be assigned to this arm (Arm B). Participants in this arm will complete TURBT with immediate intravesical instillation of epirubicin (50 mg) within 24 hours after surgery. During the induction phase (the first 1 month after surgery), participants will receive 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). In the next 6 months, participants will continue the intravesical instillation treatment with epirubicin (once a month, 50 mg). Participants will visit the clinic once every 2 weeks for checkups and tests in the first month, and once every 3 months after the first month. Receives: Drug: Irinotecan liposome II combination therapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow suppression (Grade four)
- Absolute Neutrophil Count < 0.5*10^9/L
- Platelet <25*10^9/L
- leukocyte <1.0*10^9/L
Measured: 4 weeks
Secondary outcomes (5)
Safety and adverse events
The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.
Measured: 2 months
Objective remission rate (Arm A available)
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.
Measured: 4 weeks
Recurrence-free survival (Arm B available)
The time from TURBT surgery to recurrence or the end of follow-up.
Measured: 3-6 months
BLM Lactylation of tumor tissues
The BLM lactylation of tumor tissue
Measured: 4 weeks
The levels of DNA double-strand break and homologous recombination repair in tumor tissues
The levels of DNA double-strand break and homologous recombination repair in tumor tissues are detected
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start10 Jan 2025
- Primary completion24 Apr 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Gou, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Xin Gou, Professor, Study chair, cymnk@163.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766266
- Sponsor's protocol ID
- 2024-549-02
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study outcomes and follow-up information will be available after paper publication.
Publications
Li X, Zhang C, Mei Y, Zhong W, Fan W, Liu L, Feng Z, Bai X, Liu C, Xiao M, He W, Lin T, Gou X. Irinotecan alleviates chemoresistance to anthracyclines through the inhibition of AARS1-mediated BLM lactylation and homologous recombination repair. Signal Transduct Target Ther. 2025 Jul 10;10(1):214. doi: 10.1038/s41392-025-02302-y.
PubMed 40634292