Actively Recruiting
An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the combination of intravenous RC48-ADC and JS001 as postoperative adjuvant therapy for patients with HER2-positive upper tract urothelial carcinoma (UTUC) who have undergone radical nephroureterectomy. This phase 2, open-label, single-arm trial focuses on this specific cancer type characterized by HER2 expression, aiming to improve outcomes after surgery. The study is sponsored by Jinling Hospital, China. Participants will receive six cycles of treatment every three weeks, each including RC48-ADC (Disitamab Vedotin) at 2 mg/kg combined with JS001 (Toripalimab) at 3 mg/kg intravenously. After these initial cycles, participants continue with toripalimab alone every three weeks for up to one year. The study involves a long-term follow-up period to monitor patient progress and treatment impact. Throughout the study, researchers will assess disease-free survival over five years as the primary outcome. Secondary measures include overall survival and metastasis-free survival, both tracked for five years. Participants will be closely monitored for safety and treatment adherence. The total participation duration may extend over several years to fully evaluate long-term outcomes and safety of this adjuvant therapy approach.
CONDITIONS
Brief 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
- Post radical nephro-ureterectomy 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 immunohistochemistry HER2 score 2 to 3+
- Fit and willing to receive adjuvant therapy starting within 90 days of 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, 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
- Pregnancy, breastfeeding, or unwillingness/inability to use adequate non-hormonal contraception
- Previous malignancy within last 5 years except specified controlled cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 year
Participants receive 6 cycles of RC48-ADC combined with JS001 given intravenously every 3 weeks, followed by toripalimab every 3 weeks for up to 1 year as postoperative adjuvant therapy.
Every 3 weeks during treatment cycles
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor disease-free survival, overall survival, and metastasis-free survival.
Periodic visits during follow-up
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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