Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
- Histologically or cytologic confirmed advanced hepatocellular carcinoma
- Life expectancy of more than 3 months.
- ECOG performance scale 0 - 2.
- No cirrhosis with child -pugh score A
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan.
- Adequate hepatic, renal, heart, and hematologic functions (platelets > 90 × 109/L,
neutrophil > 1.5 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper
limit of normal(ULN), and serum transaminase≤2.5×the ULN).
- signed and dated informed consent.Willingness and ability to comply with scheduled
visits, treatment plans, laboratory tests, and other study procedure.
- Pregnant or breastfeeding women
- History of any second malignancies within 3 years except cured basal cell carcinoma
of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration
- Evidence of CNS metastasis
- Intercurrence with one of the following: hypertension, coronary artery disease,
arrhythmia and heart failure
- Receiving the therapy of thrombolysis or anticoagulation
- Abuse of alcohol or drugs
- Less than 4 weeks from the last clinical trial
- Disability of serious uncontrolled intercurrence infection.
- Treatment with potent CYP3A4 inhibitors and inducer with 7 and 12 days respectively,
prior to study drug administration.