Status:
NOT_YET_RECRUITING
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
Lead Sponsor:
Renmin Hospital of Wuhan University
Conditions:
Urology
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including on...
Detailed Description
Eligible pts are aged 18 years with predominant urothelial carcinoma, who were HER2-expressing (IHC1+/2+/3+) and unsuitable for platinum-based chemotherapy; not received systematic treatment in the pa...
Eligibility Criteria
Inclusion
- Voluntary agreement to participate in the study and provision of signed and dated informed consent form.
- Male or female, aged ≥ 18 years.
- Life expectancy of ≥ 18 months.
- Pathologically and radiologically confirmed diagnosis of muscle-invasive bladder cancer (MIBC), clinical stage cT2-4aN0M0.
- Ability to provide tumor tissue specimen from the primary site for HER2 testing; HER2 expression of IHC 1+, 2+, or 3+.
- No prior systemic therapy for bladder cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate cardiac, bone marrow, hepatic, and renal function (as per the reference ranges of the investigating center).
Exclusion
- History of malignancies other than urothelial carcinoma, with the following exceptions:Patients who have received potentially curative therapy and have no evidence of the disease for 5 years.Adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other in situ carcinomas that have undergone curative resection.
- Conditions affecting drug absorption, distribution, metabolism, or excretion.
- Prior allogeneic stem cell or solid organ transplantation.Prior systemic anti-cancer therapy (including Chinese herbal medications with anti-cancer indications).Less than 4 weeks between the completion of prior therapy and the first dose of study treatment, or presence of persistent adverse events from previous treatments that have not recovered to ≤ Grade 1 per CTCAE (excluding alopecia or pigmentation).
- History or current presence of congenital or acquired immunodeficiency diseases.
- Active or documented history of autoimmune or inflammatory disorders.
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07151560
Start Date
August 30 2025
End Date
August 30 2030
Last Update
September 3 2025
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