NCT05205629Unknown不适用
A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients voluntarily entered the study and signed informed consent form (ICF);
- •Age: Be at least 18 years old and and there is no limit on the gender;
- •Clinically or histologically diagnosed as unresectable HCC;
- •There is at least one measurable lesions that meet the mRECIST standard;
- •Child-pugh classification A or B (score≤7);
- •The maximum number of TACE procedures allowed before enrolment was
- •All of those patients who had a history of prior TACE achieved complete response by previous TACE, but recurred more than 6 months later at the study entry
- •ECOG : 0 ~ 2 ;
- •Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE.
排除标准
- •Donafenib forbidden population:
- •Those who are allergic to any component of the medicine;
- •Active bleeding;
- •Active peptic ulcer;
- •Hypertension not controlled by drugs;
- •Those with severe liver insufficiency.
- •Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- •Patients with a clear past history of neurological or psychiatric disorders;
- •The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- •Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- •Unable to follow the research protocol for treatment or scheduled follow-up;
- •Any other researcher who thinks they cannot be included.
研究组 & 干预措施
Donafenib + TACE
干预措施: Donafenib combined with TACE (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: an expected average of 8 months
Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.
次要结局
- Overall survival(an expected average of 18 months)
- Objective response rate(an expected average of 12 months)
- The incidence of AEs and SAEs by NCI-CTCAE v5.0(an expected average of 18 months)
- Disease control rate(an expected average of 12 months)
- Time to untreatable progression(an expected average of 12 months)
- Conversion rate(an expected average of 18 months)
研究者
研究点 (1)
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