Clinical trial NCT01556815: Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Official title: Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]
HBV
Keywords: Hepatocellular Carcinoma
Sorafenib
Transarterial Chemoembolization
HBV
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.


Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
* BCLC stage B
* Child-Pugh class A
* ECOG performance status of 0
* 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 18-80 years
* Haematology:Absolute neutrophil count (ANC) \> 1 x 109/L, Platelet count \> 40 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5
* Biochemistry:Total bilirubin \< 2 mg/dL Serum creatinine \< 1.5 x the upper limit of normal
* Life expectancy of \> 3 months

Exclusion Criteria:

* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 x the upper limit of normal
* Other severe concomitant disease that may reduce life expectancy
* uncontrolled hypertension
* Pregnancy (positive serum pregnancy test) or lactation
* Uncontrolled hypertension
* 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

Primary outcomes:
measure: Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
timeFrame: 1 year
Secondary outcomes:
measure: safety of sorafenib in combination with TACE
timeFrame: 6 months
measure: Survival in the two treatment groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinlong Song, MD
role: PRINCIPAL_INVESTIGATOR
References: