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

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ClinicalTrials.gov Identifier: NCT01192971
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Eighty-One Hospital of People's Liberation Army
Information provided by:
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: Apatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. TTP (Time To Progression) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Overall Survival safety [ Time Frame: 8 weeks ]
  2. DCR (Disease control rate [ Time Frame: 8 weeks ]
  3. ORR (objective response rate) [ Time Frame: 8 weeks ]
  4. QoL (quality of life) [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192971


Locations
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
Investigators
Principal Investigator: Shukui Qin, Dr Millitary Eighty-one Hosiptal

Responsible Party: Dr Qin Shukui, Millatary Eighty-one Hospital
ClinicalTrials.gov Identifier: NCT01192971     History of Changes
Other Study ID Numbers: HENGRUI20100510
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

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

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