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Trial Title:
A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
NCT ID:
NCT05917158
Condition:
Carcinoma
Upper Tract Urothelial Carcinoma
UTUC
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48-ADC and JS001
Description:
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.
Arm group label:
RC48-ADC and JS001
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.
Criteria for 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 pN0-3 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Le Qu, M.D.
Phone:
15720625951
Email:
septsoul@hotmail.com
Start date:
November 23, 2022
Completion date:
December 2028
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917158
