TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Phase 2

• Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]; Carcinoma, Hepatocellular
• Interventions: Procedure: TACE; Drug: sorafenib combined with TACE

• Registration Number: NCT01605734
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25
• Study Start: 2012-07
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
• BCLC stage B or C
• Child-Pugh class score≤8
• ECOG performance status ≤2
• Etiology: Hepatitis B virus(HBV) infection
• Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
• Patient must be able to comply with the protocol
• Age 18-75 years
• Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
• Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal.
• Life expectancy of > 3 months

Exclusion Criteria

• BCLC stage D
• Child-Pugh Score≥9
• Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
• Preexisting or history of hepatic encephalopathy
• uncontrolled hypertension
• Pregnancy (positive serum pregnancy test) or lactation
• Serious, non-healing wound, ulcer, or bone fracture
• Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
• Other severe concomitant disease that may reduce life expectancy
• Risk of allergic reactions to the study drugs
• Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TACE	TACE	TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated
Group Combination	sorafenib combined with TACE	All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

Primary Outcome Measures

Name	Time	Method
Time to Progression	1 year	Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week

Secondary Outcome Measures

Name	Time	Method
FACT-Hep	six months	FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks
Disease control rate	six months after TACE	CR+PR+SD
Safety	six months	Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
PFS and OS	two years	The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively
Number of TACE sessions and the interval time between two TACE sessions	2 years
AFP	six months

Trial Locations

Locations (5)

Shandong Medical Imaging Research Institute; 🇨🇳 Jinan, Shandong, China

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China

the Affiliated Hospital of Medical College Qingdao University; 🇨🇳 Qingdao, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China