NCT05889325尚未招募不适用
Efficacy and Safety of Irinotecan-eluting HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy for Unresectable Colorectal Liver Metastases
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Both drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) are recommended for unresectable colorectal liver metastases (CRLM) treatment. However, the combined application of DEB-TACE and HAIC is not widely accepted. The aim of this single-center retrospective study was to evaluate the efficacy and safety of Irinotecan-eluting HepaSphere chemoembolization combined with HAIC for unresectable CRLM
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
- •Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable)
- •Subjects must have at least one measurable lesion per RECIST v1.1
- •Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) as interventional therapy during the observation period
- •Child-Pugh: A-B
- •ECOG: 0-2.
排除标准
- •Other malignant tumors in the past 5 years
- •Drug-eluting beads from other manufacturers were used during DEB-TACE
- •DEB-TACE combined with HAIC 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 years
Progression-free survival is defined as the time from the start of treatment HepaSphere DEB-TACE plus HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first
次要结局
- Objective Response Rate (ORR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Duration of Response (DoR)(Up to 3 years)
研究者
研究点 (1)
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