Actively Recruiting
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
Led by RemeGen Co., Ltd. · Updated on 2024-07-11
24
Participants Needed
6
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
CONDITIONS
Official Title
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consent to participate and sign informed consent form
- Male or female aged 18 to 75 years
- Histologically confirmed high-risk (including very high-risk) non-muscle invasive bladder urothelial carcinoma
- No resectable tumor after transurethral resection of bladder tumor (residual carcinoma in situ allowed)
- Considered unsuitable for or refused radical bladder surgery
- Tumor tissue with HER2 expression of 1+, 2+, or 3+ by immunohistochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate heart, bone marrow, liver, kidney, and coagulation function
You will not qualify if you...
- Invasive bladder cancer at stage T2 or higher, or with lymph node or distant metastasis
- Urothelial carcinoma outside the bladder (urethra, ureter, or renal pelvis)
- Any other antitumor therapy within 4 weeks before study treatment
- Planned major surgery during the study or within 4 weeks before the first dose
- Known allergy to Disitamab Vedotin or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sun Yat-sen Memorial Hospital,SunYat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
2
Tongji Hospital
Wuhan, Hubei, China
Not Yet Recruiting
3
Hunan Cancer hospital
Changsha, Hunan, China
Actively Recruiting
4
The first affiliated hospital with nanjing medical universtity
Nanjing, Jiangsu, China
Not Yet Recruiting
5
West China Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
6
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
Research Team
H
Hong Luo
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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