Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389422
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Pembrolizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is a single-center single-arm open-label study that includes patients meeting the inclusion criteria liver-GTV volume 700ml or estimated liver-GTV V5 300ml with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy with a gross tumor dose of 25Gy5f and a maximum dose of 35Gy5f at the tumor center One week before or during the radiotherapy patients receive concurrent Pembrolizumab at a dose of 200mg Subsequently Pembrolizumab is administered intravenously every 3 weeks Follow-up examinations are conducted 1-3 months post-radiotherapy Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications Maintenance therapy is continued until disease progression or intolerance The primary endpoint is median overall survival mOS and secondary endpoints include objective response rate ORR progression-free survival PFS and toxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None