Carcinoma Clinical Trial
— 1Official title:
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 (UTUC)
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Written informed consent - =18 years of age - Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted. - Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). - Pathological tissue immunohistochemistry HER2 2~3+ - Fit and willing to receive adjuvant therapy with first cycle to be commenced within 30 days of radical nephro-ureterectomy if allocated - ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1. - Available for long-term follow-up Exclusion Criteria: - Evidence of distant metastases - Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology - Un-resected macroscopic nodal disease - Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible) - Significant co-morbid conditions that would interfere with administration of protocol treatment - Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active); - Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry. |
Country | Name | City | State |
---|---|---|---|
China | Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival (DFS) | 5-year Disease-free survival | 5 years | |
Secondary | Overall survival (OS) | 5-year Overall Survival | Patients followed-up for 5 years | |
Secondary | Metastasis free survival (MFS) | 5-year Metastasis free survival | Patients are followed up for 5 years |
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