Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Transarterial chemoembolization (TACE) is widely applied and shows good efficacy in advanced hepatocellular carcinoma (HCC). Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity in the treatment of HCC. Several studies have described the comparison between HAIC and TACE or TACE combined with HAIC. However, the evaluation between TACE plus HAIC and HAIC is rarely reported. Here, we will evaluate the performance of HepaSphere DEB-TACE combined with HAIC (HEPA-HAIC) comparing to HAIC in patients with advanced HCC
详细描述
This is a double-arm, retrospective, observational study. The patients diagnosed as advanced HCC and treated with HepaSphere plus HAIC or single HAIC in the interventional therapy department of Peking University Cancer Hospital & Institute from May 2018 to May 2022. These patients are grouped into two cohorts. One is HEPA-HAIC group, the other is HAIC group. To access the effect of HepaSphere plus HAIC and single HAIC on the treatment of advanced HCC, the treatment efficacy and safety will be analyzed between these two cohorts. To avoid the selection bias, Propensity score matching (PSM) will be also conducted. The primary endpoints are progression-free survival (PFS) and overall survival (OS); the secondary endpoint includes objective response rate (ORR), disease control rate (DCR) and safety
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old
- •Gender: no limitation
- •Diagnosed as primary hepatocellular carcinoma histologically or clinically
- •Imaging data within 31 days at enrollment and at least one measurable lesion (according to mRECIST criteria) is available
- •Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) or HAIC alone during the observation period
- •Child-Pugh: A-B
- •ECOG: 0-2.
排除标准
- •Other cancer diseases are co-existed
- •Drug-eluting beads from other manufacturers were used during DEB-TACE
- •DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy
- •Pre- or post-surgery relevant examination results were unavailable
- •Imaging information for effectiveness evaluation was unavailable
- •Follow-up failure due to patient information errors, loss, refusal, etc
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 3 year
Progression-free survival is defined as the time from the start of treatment DEB-TACE plus HAIC or HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first
Overall Survival (OS)
时间窗: Up to 3 year
Overall survival is defined as the time from the start of treatment with DEB-TACE plus HAIC or HAIC until death due to any cause
次要结局
- Duration of Response (DoR)(Up to 3 years)
- Objective Response Rate (ORR)(Up to 3 year)