Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
Study NCT ID:
NCT05286320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-02
First Post:
2022-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With Stereotactic Body Radiotherapy for Hepatocellular Carcinoma Patients With Portal Vein Thrombosis.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-09
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:
HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.
Detailed Description:
Protocol treatment includes : Pembrolizumab is intravenously infused every 3 weeks and lenvatinib is orally given every day for a total of 2 years. SBRT (5 fractions within 17 days) to the PVTT and adjacent connecting HCC tumor is delivered in the second cycle of pembrolizumab, with the discontinuation of lenvatinib 7 days before and after SBRT.
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?: