Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT03839550
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2019-02-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combine Apatinib Mesylate With PD-1 Antibody SHR-1210 for HCC With High Risk of Recurrence After Radical Resection
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
The Multi-center, Randomized and Controlled Phase II Trail of Apatinib Mesylate Tablets Combined With PD-1 Antibody SHR-1210 for Adjuvant Treatment of Patients With High Recurrence Risk After Radical Operation of Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2019-02
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:
The purpose of this study is to assess the efficacy and safety of Apatinib Mesylate combined with PD-1 antibody SHR-1210 in HCC patients with high risk of disease recurrence contained microsatellite lesions, microvascular invasion(MVI) or secondary and above portal vein tumor thrombosis (PVTT) after radical resection. Patients will be randomized 1:1 either to the experimental arm to receive Apatinib Mesylate and PD-1 antibody SHR-1210 or to the standard therapy arm of hepatic arterial infusion(HAI) .
Detailed Description:
Hepatocellular carcinoma (HCC) is a common malignancy worldwide, which is the third cause of cancer related deaths. Radical hepatic resection is one of the most potentially curative treatments for HCC. Unfortunately, the long-term survival after radical hepatic resection is unsatisfactory because of the high incidence of tumor recurrence with the recurrence rates at 2 and 5 years are approximately 50 % to 60 % and 80 %,respectively. Microsatellite lesions, microvascular invasion (MVI) , or portal vein tumor thrombosis (PVTT) are the main risk factors for poor prognosis in HCC.
HCC is a typical vascular-rich tumor, and its occurrence, development, metastasis and invasion are closely related to angiogenesis. Due to the long-term chronic inflammatory response of the liver, the establishment and development of HCC can be induced by creating an immunosuppressive microenvironment, including up-regulation of PD-1 receptors. Therefore, immunotherapy is also considered to be a potential effective method for advanced HCC treatment. And there is little convincing evidence indicating that adjuvant therapy reduces the risk of recurrence after hepatic resection. Furthermore, no standard regimen has been established.
In the present study, we assessed the efficacy and safety of Apatinib Mesylate that is Small molecule anti-angiogenic targeted drugs /PD-1 antibody SHR-1210 combination therapy for surgically resected HCCs with high incidence of tumor recurrence containing microsatellite lesions, microvascular invasion(MVI) or secondary and above portal vein tumor thrombosis (PVTT).
HCC is a typical vascular-rich tumor, and its occurrence, development, metastasis and invasion are closely related to angiogenesis. Due to the long-term chronic inflammatory response of the liver, the establishment and development of HCC can be induced by creating an immunosuppressive microenvironment, including up-regulation of PD-1 receptors. Therefore, immunotherapy is also considered to be a potential effective method for advanced HCC treatment. And there is little convincing evidence indicating that adjuvant therapy reduces the risk of recurrence after hepatic resection. Furthermore, no standard regimen has been established.
In the present study, we assessed the efficacy and safety of Apatinib Mesylate that is Small molecule anti-angiogenic targeted drugs /PD-1 antibody SHR-1210 combination therapy for surgically resected HCCs with high incidence of tumor recurrence containing microsatellite lesions, microvascular invasion(MVI) or secondary and above portal vein tumor thrombosis (PVTT).
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?: