NCT05917158招募中2 期
An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)
Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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~
- •Available for long-term follow-up
排除标准
- •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.
研究组 & 干预措施
RC48-ADC and JS001
Experimental
干预措施: RC48-ADC and JS001 (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 5 years
5-year Disease-free survival
次要结局
- Metastasis free survival (MFS)(Patients are followed up for 5 years)
- Overall survival (OS)(Patients followed-up for 5 years)
研究者
Le Qu
Associate chief urologist
Jinling Hospital, China
研究点 (1)
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