Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC

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.

Trial Details

NCT ID
NCT07296705
Phase
PHASE2
Sponsor
Fujian Medical University Union Hospital
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Zanidatamab
  • Tislelizumab
  • Cisplatin
  • Gemcitabine
  • Nab-paclitaxel
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Putian, Fujian, China|25.43944,119.01028
  • Quanzhou, Fujian, China|24.91389,118.58583
  • Sanming, Fujian, China|26.24861,117.61861

Key Eligibility Criteria

  • Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment sche…
  • 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 a…
  • Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.

For full eligibility, visit ClinicalTrials.gov.

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