Status:
NOT_YET_RECRUITING
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fujian Cancer Hospital
Conditions:
Bladder (Urothelial, Transitional Cell) Cancer
NMIBC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
HERO: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined with Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients with HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder C...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 years.
- 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).
- 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.
- HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
- Unwillingness or ineligibility to undergo radical cystectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
- Signed informed consent form (ICF).
- Exclusion Criteria
- 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.
- Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
- History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
- Prior therapy with any other type of HER2-targeted inhibitor.
- Major surgery within 2 weeks prior to randomization.
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT07207824
Start Date
December 1 2025
End Date
December 1 2030
Last Update
October 6 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230