Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Down stage rate
研究概览
简要总结
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
详细描述
The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months;
- •Number of tumors ≤ 3;
- •Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
- •Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus;
- •Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked;
- •Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
- •No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
- •Leukocyte count ≥ 3.0 × 109/L；
- •Hemoglobin ≥ 8.5g/dl;
- •Platelet count ≥ 50 × 109/L；
- •The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds;
- •Serum creatinine was less than 1.5 times of the upper limit of normal;
- •Patients and / or family members agree to join the clinical trial and sign the informed consent form
排除标准
- •Diffuse hepatocellular carcinoma;
- •Portal vein tumor thrombus;
- •Combined with tumor thrombus of hepatic vein and inferior vena cava;
- •Patients with lymph node metastasis and extrahepatic distant metastasis;
- •The liver function was classified as child Pugh C and could not be improved by liver protection treatment;
- •Arteriovenous fistula or arterioportal fistula with ineffective intervention;
- •Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency;
- •Intractable massive ascites;
- •ECoG physical fitness score > 2 points;
- •Combined with active infection, especially bile duct inflammation;
- •Serious heart, lung, kidney, brain and other important organ diseases;
- •Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
研究组 & 干预措施
TACE combined with Lenvatinib
Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg).
干预措施: TACE combined with Lenvatinib (Drug)
结局指标
主要结局
Down stage rate
时间窗: 4 months
if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.
次要结局
- Objective response rate(3 years)
- TACE frequency and ablation frequency(3 years)
- RFS(3 years)
- Changes of liver and kidney function(3 years)
研究者
Huang Jinhua
Professor
Sun Yat-sen University