TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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