A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

This study has been completed.
Eighty-One Hospital of People's Liberation Army
Information provided by:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
First received: August 30, 2010
Last updated: April 2, 2015
Last verified: April 2015
This phase II trial will be studying how well Apatinib working in patients with liver cancer.

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: Apatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • TTP (Time To Progression) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • DCR (Disease control rate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • ORR (objective response rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • QoL (quality of life) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 850
Arm 850: Experimental apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patient withdrawal of consent
Drug: Apatinib
apatinib p.o. once daily for 4 weeks
Experimental: B750
B750: apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Apatinib
apatinib p.o. once daily for 4 weeks


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192971

China, Jiangsu
Nanjin Military Eighty -one Hosiptal
Nanjin,, Jiangsu, China, 210002
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Eighty-One Hospital of People's Liberation Army
Principal Investigator: Shukui Qin, Dr Millitary Eighty-one Hosiptal
  More Information

No publications provided

Responsible Party: Dr Qin Shukui, Millatary Eighty-one Hospital
ClinicalTrials.gov Identifier: NCT01192971     History of Changes
Other Study ID Numbers: HENGRUI20100510 
Study First Received: August 30, 2010
Last Updated: April 2, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
hcc, apatinib, phase II, cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 11, 2016