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

Korábbi kezelés

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

Más betegség

• Un-resected macroscopic nodal disease
• Significant co-morbid conditions that would interfere with administration of protocol treatment
• 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.

Egyéb

• Evidence of distant metastases
• Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
• 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);

• 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 pN0-2 M0 or pTany N1-2 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 90 days of radical nephro-ureterectomy if allocated
• ECOG(Eastern Cooperative Oncology Group) performance is 0~2.
• Available for long-term follow-up