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RECRUITING
NCT07296705
PHASE2

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

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-10-25

Completion Date

2029-12

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

Zanidatamab

Zanidatamab (1,800 mg for patients \<70 kg or 2,400 mg for patients ≥70 kg, administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant regimen. After completion of neoadjuvant therapy, disease status is reassessed. Patients achieving a clinical complete response (cCR) may continue zanidatamab every 3 weeks for 2-4 cycles as part of bladder-preserving treatment; those without cCR may receive radiotherapy or partial cystectomy followed by zanidatamab every 3 weeks for 2-4 cycles, or undergo radical cystectomy without further zanidatamab treatment.

DRUG

Tislelizumab

Tislelizumab (200 mg administered intravenously every 3 weeks) is administered for 4 cycles as neoadjuvant therapy. After completion of 4 cycles, disease status is reassessed. Patients achieving a clinical complete response (cCR) may proceed with selective bladder preservation and continue tislelizumab every 3 weeks for 12 cycles; those without cCR may receive radiotherapy or partial cystectomy followed by tislelizumab every 3 weeks for 12 cycles, or undergo radical cystectomy with adjuvant tislelizumab every 3 weeks for 12 cycles.

DRUG

Cisplatin

Cisplatin (70 mg/m² administered intravenously every 3 weeks ) for 4 cycles is included in the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.

DRUG

Gemcitabine

Gemcitabine (1,000 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.

DRUG

Nab-paclitaxel

Nab-paclitaxel (125 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for ineligible or refused cisplatin-based chemotherapy.

Locations (12)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Provincial Hospital Affiliated to Fuzhou University

Fuzhou, Fujian, China

Affiliated Hospital of Putian University

Putian, Fujian, China

Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, China

Sanming First Hospital

Sanming, Fujian, China

The First Affi liated Hospital of Xiamen University

Xiamen, Fujian, China

Zhangzhou Affiliated Hospital to Fujian Medical University

Zhangzhou, Fujian, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China