A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
Phase 2
Recruiting
- Conditions
- UTUCCarcinomaUpper Tract Urothelial Carcinoma
- Interventions
- Drug: RC48-ADC and JS001
- Registration Number
- NCT05917158
- Lead Sponsor
- Jinling Hospital, China
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RC48-ADC and JS001 RC48-ADC and JS001 -
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 5 years 5-year Disease-free survival
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
🇨🇳Nanjing, Jiangsu, China