Efficacy and Safety of the Combination of Transarterial Therapies With Donafenib Plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma: A Retrospective Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- the objective response rate (ORR)
研究概览
简要总结
This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.
详细描述
Data of Patients who have received Triplet therapy ( transarterial therapies+donafenib+Anti-PD-1 Antibody）will be collected，excluding incomplete data.
The primary endpoint was the objective response rate (ORR)，Secondary endpoints included disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS)， as well as adverse event.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically or histopathologically diagnosed HCC;
- •not suitable for curative surgery, or local ablation;
- •age 18~75 years；
- •Barcelona Clinic Liver Cancer (BCLC) Stage-B or C HCC; 5) Child-Pugh score A or B7; 6) Eastern Cooperative Group (ECOG) performance status ≤1.;
- •7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
排除标准
- •1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data.
结局指标
主要结局
the objective response rate (ORR)
时间窗: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
次要结局
- disease control rate (DCR)(From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months))
- The progression-free survival rate (PFSR)(From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months))
- The overall survival rate (OSR)(From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months))
- The progression-free survival time (mPFS)(From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months))
- The median overall survival time (mOS)(From the start date of the Treatment until date of death from any cause (max 24 months))
- Adverse events(From the begining triplet therapy until date of death from any cause (max 24 months))