NCT05278195Unknown不适用
Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this study is to id
transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- •Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- •Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- •TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
- •Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
- •Has repeated measurable intrahepatic lesions according to RECIST v1.1;
排除标准
- •Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- •Unable to meet criteria of combination timeframe described above;
- •Missing follow-up data;
结局指标
主要结局
Overall Survival(OS)
时间窗: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
次要结局
- Accuracy(baseline)
- Sensitivity(baseline)
- Specificity(baseline)
- The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode(baseline)
研究者
Gao-jun Teng
President
Zhongda Hospital
研究点 (1)
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