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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02150317

Acronym

TACE

Enrollment

180

Registered

2014-05-29

Start date

2014-01-31

Completion date

2016-12-31

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Sorafenib

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.

Interventions

PROCEDURETACE+Sorafenib

TACE followed by Sorafenib

PROCEDURETACE

TACE alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
the overall survival rate of each group	3 years

Countries

China

Contacts

Primary ContactAi-jun Li, M.D.

yinlei409@hotmail.com0086-21-81875531

Backup ContactLei Yin, M.D.

dermatology2008@126.com0086-21-81875532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026