Actively Recruiting
Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
Led by Fujian Medical University Union Hospital · Updated on 2025-12-22
25
Participants Needed
12
Research Sites
214 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and assessment schedule
- Age between 18 and 85 years at the time of consent
- Residual urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 confirmed by histology and imaging
- Availability of TURBT tumor tissue and pathology report (fresh tissue or unstained slides)
- HER2-positive status defined as IHC 2+ or 3+
- No prior anti-HER2-directed therapy or PD-(L)1 therapy
- ECOG performance status of 0 to 2
- Adequate organ function based on recent screening labs, including specified blood counts, clotting tests, liver enzymes, and bilirubin levels
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after last dose
- Non-sterilized men must agree to use effective contraception during the study and for 120 days after last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Uncontrolled infection requiring systemic therapy
- Diagnosis of another malignancy within the past 5 years
- Major surgery or significant trauma within 28 days before enrollment (except vascular access device placement or TURBT)
- Prior radiotherapy to the bladder for bladder cancer
- Active autoimmune disease requiring systemic treatment
- Recent cardiac or cardiovascular events within specified timeframes, including chest pain, pulmonary embolism, myocardial infarction, heart failure, arrhythmia, stroke, or abnormal QTc interval
- Left ventricular ejection fraction below 50%
- History of acute myocardial infarction or ischemic stroke within 6 months
- Active infections such as HIV, syphilis, tuberculosis, hepatitis B or C
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary disease
- Known allergy to any study drug
- Participation in another clinical study except observational or follow-up phases
- Any other condition deemed by the investigator to cause ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Fujian Provincial Hospital Affiliated to Fuzhou University
Fuzhou, Fujian, China, 350001
Actively Recruiting
3
Affiliated Hospital of Putian University
Putian, Fujian, China, 351106
Actively Recruiting
4
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, China, 362002
Actively Recruiting
5
Sanming First Hospital
Sanming, Fujian, China, 365099
Actively Recruiting
6
The First Affi liated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
7
Zhangzhou Affiliated Hospital to Fujian Medical University
Zhangzhou, Fujian, China, 363000
Actively Recruiting
8
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
9
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
12
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325035
Actively Recruiting
Research Team
S
Shaoxing Zhu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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