💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria
1. Age ≥ 18 years.
2. Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
3. Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
4. HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
5. Unwillingness or ineligibility to undergo radical cystectomy.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
7. Signed informed consent form (ICF).
Exclusion Criteria
1. Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
4. Prior therapy with any other type of HER2-targeted inhibitor.
5. Major surgery within 2 weeks prior to randomization.
6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
💊
What it tests
- Active Comparator: BCG induction and maintenance
- DV + BCG induction and maintenance
Fudan University Shanghai Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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