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Recruiting Phase 2

A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

NCT05917158 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2022-11-23
Last updated
2025-01-22

Condition(s) studied

CarcinomaUpper Tract Urothelial CarcinomaUTUC

Investigational drug(s) / intervention(s)

RC48-ADC and JS001

RC48-ADC and JS001: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Disease-free survival (DFS) — 5 years
    5-year Disease-free survival

Trial sites (1)

FacilityCityRegionStatus
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05917158 on ClinicalTrials.gov ↗ ← All trials in China