A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
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)
Jinling Hospital, China
30 participants
Nov 23, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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.
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Interventions
Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg/kg in combination with JS001 (Toripalimab) 3mg/kg intravenously, followed by toripalimab (3 mg/kg) every 3 weeks for up to 1 year.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05917158