Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01605734
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01605734
Study Brief:
Protocol Section:
NCT01605734