A Study of Apatinib for Advanced Hepatocellular Carcinoma Patients After First-line Treatment Failure
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|ClinicalTrials.gov Identifier: NCT02772029|
Recruitment Status : Unknown
Verified May 2016 by Sheng Guan, The First Affiliated Hospital of Zhengzhou University.
Recruitment status was: Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its incidence matches mortality, reflecting the poor prognosis of this disease. The surgical resection rate of HCC is low, and the prognosis is poor. Although transarterial chemoembolization (TACE) is the main treatment for HCC patients who are not candidates for surgical resection, it is not considered a curative procedure. For HCC, poor TACE efficacy or TACE failure may be related to tumor angiogenesis of the residual disease. Among the many regulatory factors in tumor angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular endothelial growth factor (VEGF) play vital roles in this process.
Sorafenib is the first systemic treatment drug, which has been approved by the FDA for advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity, Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor growth inhibitory activity on glioma, this study aims to further verify the efficacy and safety of Apatinib for first-line treatment failure hepatocellular carcinoma patients, the primary endpoint is time to progression(TTP).
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Apatinib Mesylate Tablets||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Apatinib for Advanced Hepatocellular Carcinoma Patients After First-line Treatment Failure|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Apatinib Mesylate Tablets
Apatinib (Apatinib Mesylate Tablets) 750 mg is administered orally daily, until disease progression or intolerable toxicity.
Drug: Apatinib Mesylate Tablets
Apatinib 750 mg is administered orally daily, until disease progression or untolerable toxicity.
Other Name: Apatinib
- time to progression [ Time Frame: 1 year ]
- overall survival [ Time Frame: 1 year ]
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): NCT02772029
|Contact: mingxing email@example.com|
|Principal Investigator:||sheng guan||The First Affiliated Hospital of Zhengzhou University|