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Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Phase 2
18 Years
75 Years
Open (Enrolling)
Advanced Hepatocellular Carcinoma

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Trial Information

Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

TTP (Time To Progression)

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Shukui Qin, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Millitary Eighty-one Hosiptal


China: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2011

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • hcc, apatinib, phase II, cancer
  • Carcinoma
  • Carcinoma, Hepatocellular