Ablation of Pulmonary Oligometastasis Combined With System Compared System Therapy for Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.
详细描述
Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. This multicenter study focuses on the management of ablation of oligometastasis therapy combined with systemic therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- •presence of pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
- •metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
- •receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
- •undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
- •classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •no history of other malignancies.
- •life expectancy more than 3 months;
- •agreed to participated in this clinical trial;
- •Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
排除标准
- •intermediate HCC;
- •age < 18 years or > 75 years;
- •advanced HCC with more than five metastases;
- •no response to Lenvatinib;
- •metastases size > 5 cm;
- •life expectancy less than 3 months.
研究组 & 干预措施
Ablation+system group
Participants received ablation of plumonary combined systemic therapy
干预措施: Ablation (Procedure)
Ablation+system group
Participants received ablation of plumonary combined systemic therapy
干预措施: system therapy (Drug)
System group
Participants received systemic therapy
干预措施: system therapy (Drug)
结局指标
主要结局
Progression-Free-Survival
时间窗: 12 months
Progression was defined as progressive disease by independent radiologic review
次要结局
- Overall survival (OS)(24 months)
- Objective response rate (ORR)(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University