TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients

A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients

This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.

The aim of this study is to include 40 patients with middle-advanced Hepatocellular Carcinoma .These patients were randomly allocated to TACE treatment group or TACE+Anlotinib treatment group.The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Inclusion Criteria:

1. Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney;
2. Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ;
3. Liver function child-pugh class A or B; Karnofsky (KPS) score > 60 points;
4. Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation.

5.18~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months.

Exclusion Criteria:

1. Subject has contraindications to chemotherapy;
2. Subject has obstacle in the function of major organs such as heart, lung, liver and kidney;
3. Severe coagulation dysfunction (prothrombin time > 18 s or hemorrhagic tendency);
4. Uncontrollable hypertension and portal hypertension;
5. Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus;
6. A large amount of ascites or refractory ascites;
7. With distant metastasis.