The Comprehensive Analysis of Efficacy and Safety of CalliSpheres® Drug-eluting Beads Transarterial Chemoembolization in 367 Patients With Liver Cancer: a Multiple-center Cohort Study (CTILC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 主要终点
- Treatment response
研究概览
简要总结
Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. This study aimed to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS), overall survival (OS) and less common adverse events (AEs) in liver cancer patients.
Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed as primary HCC, primary ICC or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to American Association for the Study of the Liver Diseases (AASLD) guidelines;
- •Age above 18 years;
- •About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing.
- •Able to be followed up regularly;
- •Life expectancy above 12 months.
排除标准
- •History of liver transplantation;
- •History of hematological malignances;
- •Severe hepatic failure or renal failure;
- •Contraindication for angiography, embolization procedure or artery puncture;
- •Patients with cognitive impairment, or unable to understand the study consents.
- •Women in gestation or lactation period.
结局指标
主要结局
Treatment response
时间窗: One-three months after DEB-TACE treatment
Treatment response was assessed at 1-3 months after DEB-TACE treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) by enhanced computerized tomography (CT) or magnetic resonance imaging (MRI) examination.
次要结局
- Adverse events (AEs)(During DEB-TACE operation and 1 month after DEB-TACE operation.)
- overall survival(The median follow-up duration was 171 (range from 38 to 404) days.)
- Liver function evaluation(One week post and 1-3 months post DEB-TACE treatment.)
研究者
guoliang shao
Vice president of Zhejiang Cancer Hospital
Zhejiang Cancer Hospital