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

Advanced Hepatocellular Carcinoma Clinical Trial

— TACE  

Official title:

A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02150317
• Other study ID #: EHBHKY2013-001-08
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2014
• Last updated: March 28, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Ai-jun Li, M.D.
• Phone: 0086-21-81875531
• Email: yinlei409[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• TACE+Sorafenib
TACE followed by Sorafenib
• TACE
TACE alone

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall survival rate of each group		3 years	No