Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT03066557
Status:
UNKNOWN
Last Update Posted:
2017-02-28
First Post:
2017-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Combination of TACE With Apatinib in Patients With Hepatocellular Carcinoma
Sponsor:
Jiangsu Cancer Institute & Hospital
Organization:
Study Overview
Official Title:
Study of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Apatinib in Patients With Hepatocellular Carcinoma Trial
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of previous clinical studies, we intend to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of previous clinical studies, we intend to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
Detailed Description:
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 Hepatocellular carcinoma, this study aims to further verify the efficacy and safety of Apatinib for hepatocellular carcinoma patients who are not candidates for curative surgery, the primary endpoint is Progression Free Survival (PFS).
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 Hepatocellular carcinoma, this study aims to further verify the efficacy and safety of Apatinib for hepatocellular carcinoma patients who are not candidates for curative surgery, the primary endpoint is Progression Free Survival (PFS).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: