TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Objective remission rate（ORR）
研究概览
简要总结
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
详细描述
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.
- •Age ≥ 18 years at time of study entry.
- •Child-Pugh scores <
- •Performance status (PS) ≤ 2 (ECOG scale).
- •BCLC stage B, some patients in stage C (Vp2-3).
- •The patient and/or his family agreed to join the clinical trial and sign the informed consent form.
排除标准
- •Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).
- •Main portal vein tumor thrombus or complicated with extrahepatic metastasis.
- •Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
- •Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.
- •Estimated life expectancy of <3 months.
- •There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil<1.5×109/L, PLT<50×109/L. The INR>2.
- •Renal dysfunction：serum creatinine (SCR) >176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) <30 mL/min.
- •Serious heart, lung, brain or other important organ diseases.
- •Pregnant or lactating women.
- •cannot cooperate with TACE operation and sign informed consent form.
研究组 & 干预措施
TACE Combined with Lenvatinib
干预措施: Lenvatinib (Drug)
TACE Combined with Lenvatinib
干预措施: TACE (Procedure)
结局指标
主要结局
Objective remission rate（ORR）
时间窗: 2 years
ORR according to modified RECIST for Hepatocellular Carcinoma
Time to progression（TTP）
时间窗: 2 years
The time from the beginning of randomization to the tumor progression of the patient
次要结局
- Overall survival(5 years)
- Adverse Events(2 years)