A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial will be studying how well Apatinib working in patients with liver cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborator: Eighty-One Hospital of People's Liberation Army
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.