A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
RC48-ADC and JS001
DrugPatients 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: RC48-ADC and JS001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival (DFS)
5-year Disease-free survival
Time frame
5 yearsSecondary outcomes
1
Overall survival (OS)
5-year Overall Survival
Time frame
Patients followed-up for 5 years2
Metastasis free survival (MFS)
5-year Metastasis free survival
Time frame
Patients are followed up for 5 yearsSponsors and contacts
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Source ClinicalTrials.gov