Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05033587
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-08-27
Brief Title:
Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma a Prospective Open-label Single-arm Exploratory Trial
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
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:
This is a prospective open-label single-arm exploratory two-stage design trial aiming to investigate safety and efficacy of AK105 with anlotinib and radiotherapy adjuvant therapy in MGMT unmethylated newly diagnosed glioblastoma
Detailed Description:
Glioblastoma is the most common and aggressive primary brain tumor in adults Treatment usually involves surgery after which chemotherapy and radiation therapy are used The Central Brain Tumor Registry of the United States CBTRUS Statistical Report primary brain and other central nervous system tumors diagnosed in the United States in 2012-2016 glioblastoma accounted for 483 of primary malignant brain tumors
The Stupp protocol has become standard of care for the treatment of newly diagnosed GBM however some MGMT unmethylated glioblastomas are still resistant to temozolomide
Immunotherapy is being studied as treatment for the cancer AK105 is a humanized monoclonal antibody that specially binds to PD-1 Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor Based on the mechanism study tumor vascular abnormalities promote tissue hypoxia and increase lactic acid thereby activating immunosuppression and inhibiting T cell function Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression
The Stupp protocol has become standard of care for the treatment of newly diagnosed GBM however some MGMT unmethylated glioblastomas are still resistant to temozolomide
Immunotherapy is being studied as treatment for the cancer AK105 is a humanized monoclonal antibody that specially binds to PD-1 Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor Based on the mechanism study tumor vascular abnormalities promote tissue hypoxia and increase lactic acid thereby activating immunosuppression and inhibiting T cell function Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression
Study Oversight
Has Oversight DMC:
None
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?:
None