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

Not Applicable

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Procedure: TACE+Sorafenib

• Registration Number: NCT02150317
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE	TACE	TACE alone
TACE+Sorafenib	TACE+Sorafenib	TACE followed by Sorafenib

Primary Outcome Measures

Name	Time	Method
the overall survival rate of each group	3 years

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China