Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-… (NCT07296705) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
China25 participantsStarted 2025-10-25
Plain-language summary
This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.
✓. Age 18 to 85 years on the date of informed consent.
✓. Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).
✓. Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
✓. HER2-positive: IHC 2+ or 3+.
✓. No prior anti-HER2-directed therapy (including but not limited to HER2 antibodies, HER2-targeting ADCs, or HER2-targeted TKIs) and no prior PD-(L)1 therapy.
✓. ECOG performance status 0-2.
✓. Adequate organ function based on screening labs obtained ≤14 days before enrollment:
✕. Diagnosis of another malignancy within the past 5 years.
✕. Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).
What they're measuring
1
Clinical Complete Response (cCR) Rate
Timeframe: At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)