The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.
详细描述
The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18-75 years;
- •RHCC diagnosed by imaging;
- •intermediate-stage RHCC (two to three lesions which at least one was >3 cm in size or more than three tumors);
- •the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
- •absence of extrahepatic metastasis or macrovascular invasion;
- •Child-Pugh class A or B;
- •TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
- •life expectance >3 months;
排除标准
- •under 18 years or over 75 years of age;
- •primary intermediate-stage HCC;
- •RHCC with more than six tumors, or single RHCC
- •(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
研究组 & 干预措施
TACE plus Lenvatinib
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day )
干预措施: TACE (Procedure)
TACE plus Lenvatinib
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day )
干预措施: Lenvatinb (Drug)
TACE plus Lenvatinib and ablation
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day ) Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.
干预措施: TACE (Procedure)
TACE plus Lenvatinib and ablation
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day ) Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.
干预措施: Ablation (Procedure)
TACE plus Lenvatinib and ablation
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day ) Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.
干预措施: Lenvatinb (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 24 months
PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.
次要结局
- Overall survival (OS)(36 month)
- Objective response rate (ORR)(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University