Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478927
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Brief Title:
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Single-Arm Prospective Open Clinical Study of Palbociclib for Backline Treatment of Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
Currently it has been demonstrated that CDK4 is highly expressed in hepatocellular carcinoma patients and is significantly associated with poor prognosis in hepatocellular carcinoma patients Palbociclib is the worlds first marketed inhibitor of the cell cycle protein-dependent kinase CDK46 which is capable of blocking cell cycle progression and inhibiting tumor cell proliferation However current evidence for the use of CDK46 inhibitors in patients with advanced hepatocellular carcinoma cells remains lacking This study used palbociclib backline treatment for patients with advanced hepatocellular carcinoma aiming to further validate the potential role of CDK46 inhibitors in the treatment of patients with advanced hepatocellular carcinoma
Detailed Description:
This study was a single arm prospective open clinical study Twenty-two patients with advanced hepatocellular carcinoma were enrolled in this study and were simultaneously treated and observed with palbociclib The efficacy and safety of palbociclib in patients with advanced hepatocellular carcinoma were evaluated by PFS ORR DCR OS and AE
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