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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05917158
Other study ID # 2022DZKY-106-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 23, 2022
Est. completion date December 2028

Study information

Verified date June 2023
Source Jinling Hospital, China
Contact Le Qu, M.D.
Phone 15720625951
Email septsoul@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 pN0-3 M0 or pTany N1-3 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 30 days of radical nephro-ureterectomy if allocated - ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1. - 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


Intervention

Drug:
RC48-ADC and JS001
Patients in group will receive 6 x 2 week cycles of JS001 (Toripalimab) 3mg/kg in combination with RC48-ADC (Disitamab Vedotin) 2mg/kg intravenously.

Locations

Country Name City State
China Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival (DFS) 5-year Disease-free survival 5 years
Secondary Overall survival (OS) 5-year Overall Survival Patients followed-up for 5 years
Secondary Metastasis free survival (MFS) 5-year Metastasis free survival Patients are followed up for 5 years
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