Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535737
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Phase 2 Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPAB
Brief Summary:
Hepatocellular carcinoma HCC is the most common liver cancer and a leading cancer death worldwide Currently atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab It is a multi-center single-arm study which all participants will receive cabozantinib Participants will continue cabozantinib until disease progression or unacceptable toxicities
Detailed Description:
Currently atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab
This is a phase II single-arm multi-center trial which all participants will receive cabozantinib Eligible patients will provide informed consent to participate the trial The study will enroll 40 patients All participants will receive cabozantinib until disease progression or unacceptable toxicities Efficacy assessment will be performed with CT scan or MRI every 8 weeks Clinical assessments and laboratory tests will be scheduled every 2-4 weeks for safety assessments
This is a phase II single-arm multi-center trial which all participants will receive cabozantinib Eligible patients will provide informed consent to participate the trial The study will enroll 40 patients All participants will receive cabozantinib until disease progression or unacceptable toxicities Efficacy assessment will be performed with CT scan or MRI every 8 weeks Clinical assessments and laboratory tests will be scheduled every 2-4 weeks for safety assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None