Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Procedure: TACE; Procedure: TACE+Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT02150317

EHBHKY2013-001-08

Details and patient eligibility

About

The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients > 18 years and <=70 years of age.
• at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
• tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
• Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
• No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
• Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
• Patients who can understand this trial and have signed information consent

Exclusion criteria

• Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
• Patients with other diseases which may affect the treatment mentioned.
• Patients with a medical history of other malignant tumors.
• Subjects participating in other clinical trials.
• liver function:Child C.
• no pathological evidence of hepatocellular carcinoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

TACE+Sorafenib

Active Comparator group

Description:

TACE followed by Sorafenib

Treatment:

Procedure: TACE+Sorafenib

TACE

Experimental group

Description:

TACE alone

Treatment:

Procedure: TACE