A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma (1)

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.