A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

Inclusion Criteria:

• Written informed consent

• ≥18 years of age

• Post radical nephro-ureterectomy for upper tract tumour with predominant TCCcomponent-squamoid differentiation or mixed TCC/SCC is permitted.

• Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing allgrossly abnormal nodes are resected).

• Pathological tissue immunohistochemistry HER2 2~3+

• Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated

• ECOG(Eastern Cooperative Oncology Group) performance is 0~2.

• Available for long-term follow-up

Exclusion Criteria:

• Evidence of distant metastases

• Pure adenocarcinoma, squamous cell carcinoma or small cell or other varianthistology

• Un-resected macroscopic nodal disease

• Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscleinvasive bladder cancer (NMIBC) will be eligible)

• Significant co-morbid conditions that would interfere with administration ofprotocol treatment

• Pregnancy; lactating women or women of childbearing potential unwilling or unable touse adequate non-hormonal contraception (male patients should also use contraceptionif sexually active);

• Previous malignancy in the last 5 years except for previous NMIBC, adequatelycontrolled non melanoma skin tumours, CIS of cervix or LCIS of breast or localisedprostate cancer in patients who have a life expectancy of over 5 years upon trialentry.