Actively Recruiting
A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
Led by Jinling Hospital, China · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.
CONDITIONS
Official Title
A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- 18 years of age or older
- Underwent radical nephroureterectomy for upper tract tumor with predominant TCC component; squamoid differentiation or mixed TCC/SCC allowed
- Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 with all grossly abnormal nodes resected
- Pathological tissue shows HER2 2+ to 3+ by immunohistochemistry
- Fit and willing to receive adjuvant therapy starting within 90 days after surgery
- ECOG performance status between 0 and 2
- Available for long-term follow-up
You will not qualify if you...
- Evidence of distant metastases
- Pure adenocarcinoma, squamous cell carcinoma, small cell carcinoma, or other variant histology
- Unresected macroscopic nodal disease
- Concurrent muscle invasive bladder cancer (non-muscle invasive bladder cancer allowed)
- Significant co-morbid conditions interfering with treatment administration
- Pregnancy, lactation, or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception; male patients must also use contraception if sexually active
- Previous malignancy within last 5 years except controlled non-muscle invasive bladder cancer, non-melanoma skin tumors, carcinoma in situ of cervix, lobular carcinoma in situ of breast, or localized prostate cancer with life expectancy over 5 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Le Qu, M.D.
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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