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

RecruitingPhase 2Ages 18 Years - anyAllJinling Hospital, China
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written informed consent * โ‰ฅ18 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.
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What it tests

  • RC48-ADC and JS001
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Where

1 site
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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