Selective Bladder Preservation After Neoadjuvant Zanidatamab Combined With Tislelizumab and Chemotherapy in Patients With HER2-Positive Muscle-Invasive Bladder Cancer: A Multicenter Study (HARBOR)

NCT07296705 Phase 2 RECRUITING

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.

Details

Lead sponsor	Fujian Medical University Union Hospital
Phase	Phase 2
Status	RECRUITING
Enrolment	25
Start date	2025-10-25
Completion	2029-12

Conditions

• Muscle Invasive Bladder Cancer (MIBC)

Interventions

• Zanidatamab
• Tislelizumab
• Cisplatin
• Gemcitabine
• Nab-paclitaxel

Primary outcomes

• Clinical Complete Response (cCR) Rate — At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)
  Proportion of participants achieving cCR at the end of neoadjuvant therapy, defined as no evidence of tumor on radiographic imaging, no residual tumor on diagnostic TURBT, and negative urine cytology

Countries

China