Actively Recruiting
Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of HER2-positive 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
Researchers are evaluating the effectiveness and safety of intravenous RC48-ADC combined with JS001 as a postoperative adjuvant treatment for patients with HER2-positive upper tract urothelial carcinoma (UTUC) who have undergone radical nephroureterectomy. This open-label, single-arm phase 2 clinical trial focuses on patients with specific tumor characteristics confirmed by pathology and HER2 testing. The study aims to improve disease-free survival over a 5-year period. Participants will receive six cycles, each lasting three weeks, of the combination treatment with RC48-ADC (Disitamab Vedotin) at 2 mg/kg and JS001 (Toripalimab) at 3 mg/kg intravenously. After these initial cycles, patients will continue with toripalimab alone at 3 mg/kg every three weeks for up to one year as part of the adjuvant therapy. This treatment plan is designed to target residual cancer cells after surgery and monitor the body's response. During the study, participants will undergo regular assessments to track disease-free survival and monitor safety. Follow-up will be long-term to observe the durability of the treatment effect. Researchers will collect clinical data including performance status, pathological findings, and any side effects. The total duration of monitoring and treatment extends through the adjuvant therapy period and includes long-term follow-up to assess outcomes and safety.
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
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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.
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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