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NCT06766266
Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment
Phase 1 trial testing Irinotecan liposome II combination therapy regimen in Non-Muscle Invasive Bladder Urothelial Carcinoma in 18 participants. Currently enrolling.
24 April 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Chongqing Medical University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 10 January 2025 |
| Primary completion | 24 April 2025 |
| Estimated completion | 24 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Irinotecan liposome II combination therapy regimen — full drug profile →
- Irinotecan liposome II combination therapy regimen — full drug profile →
Conditions studied
- Non-Muscle Invasive Bladder Urothelial Carcinoma — all drugs for Non-Muscle Invasive Bladder Urothelial Carcinoma →
Sponsor
First Affiliated Hospital of Chongqing Medical University
Who can join
18 and older, any sex, with Non-Muscle Invasive Bladder Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Irinotecan alleviates chemoresistance to anthracyclines through the inhibition of AARS1-mediated BLM lactylation and homologous recombination repair.
Li X, Zhang C, Mei Y, Zhong W, et al · · 2025 · cited 11× · PMID 40634292 · DOI 10.1038/s41392-025-02302-y -
Harnessing PDX and PDX 2.0: the next-generation paradigm for precision oncology and translational breakthroughs.
Jian C, Fu H, Wu W, Zhang N, et al · · 2026 · PMID 41699647 · DOI 10.1186/s12943-026-02594-w -
Lactate-lactylation in tumor angiogenesis and progression: mechanisms, biomarker potential, and therapeutic implications.
Wu P, Zhang J, Jiang Z, Liu X, et al · · 2026 · PMID 41593811 · DOI 10.1186/s40364-026-00898-z
Verify or expand the search:
- PubMed search for NCT06766266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Irinotecan liposome II combination therapy regimen
Trials testing the same drug.
- NCT06375473 — Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients · recruiting
Other recruiting trials for Non-Muscle Invasive Bladder Urothelial Carcinoma
Currently open trials in the same condition.
- NCT06770582 — Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy T · Phase 2 · recruiting
- NCT06503614 — A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
- NCT06396533 — Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE) · recruiting
- NCT04164082 — Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabin · Phase 2 · active not recruiting
- NCT06167356 — Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK. · recruiting
Other First Affiliated Hospital of Chongqing Medical University trials
Trials by the same sponsor.
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- NCT07409870 — An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture · not yet recruiting
- NCT07324473 — Ivarmacitinib Combined With Camrelizumab and Apatinib for Unresectable Advanced Hepatocellular Carcinoma With Acquired R · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06766266 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Chongqing Medical University
- Last refreshed: 26 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06766266.
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