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

Launched by JINLING HOSPITAL, CHINA · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of kidney cancer called upper tract urothelial carcinoma (UTUC) that is positive for a specific protein known as HER2. The treatment involves using two drugs, RC48-ADC and JS001, given through an IV after surgery to see how effective and safe they are. The goal is to help prevent the cancer from coming back after patients have had surgery to remove the tumor.

To participate, patients must be at least 18 years old and have recently undergone surgery to remove their cancer. They should have a specific type of tumor and be in good health to start treatment within 30 days after their surgery. Participants will have regular follow-ups to monitor their health and response to the treatment. It's important to know that not everyone can join; for example, those with other serious health issues or certain types of cancer won't be eligible. Overall, this trial is an opportunity for eligible patients to potentially benefit from a new treatment approach for their cancer.

Gender

ALL

Eligibility criteria

• 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 pN0-2 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
• 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.