Carcinoma, Upper Tract Urothelial Carcinoma, UTUC
Conditions
Brief 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.
Detailed description
This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.
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.
Sponsors
Jinling Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 5 years | 5-year Disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Patients followed-up for 5 years | 5-year Overall Survival |
| Metastasis free survival (MFS) | Patients are followed up for 5 years | 5-year Metastasis free survival |
Countries
China
Contacts
Primary ContactLe Qu, M.D.
Outcome results
None listed