Clinical trial NCT01605734: TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
Official title: Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]
Carcinoma, Hepatocellular
Keywords: hepatocellular carcinoma
transarterial chemoembolization
sorafenib
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Progression
timeFrame: 1 year
Secondary outcomes:
measure: FACT-Hep
timeFrame: six months
measure: Disease control rate
timeFrame: six months after TACE
measure: Safety
timeFrame: six months
measure: PFS and OS
timeFrame: two years
measure: Number of TACE sessions and the interval time between two TACE sessions
timeFrame: 2 years
measure: AFP
timeFrame: six months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Medical Imaging Research Institute
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Qingdao
country: China
facility: the Affiliated Hospital of Medical College Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinlong Song, MD
role: PRINCIPAL_INVESTIGATOR
References: