Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364007
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
Sponsor:
Sulai Liu
Organization:
Hunan Provincial Peoples Hospital
Study Overview
Official Title:
Phase II Study Evaluating the Efficacy of Tremelimumab T Plus Durvalumab D With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy HAIC in Patients Pts With Unresectable Hepatocellular Carcinoma uHCC
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:
The treatment options for unresectable HCC have rapidly developed and immunotherapy has shown significant survival benefits in hepatocellular carcinoma The STRIDE regimen of Single Tremelimumab high priming 300-mg dose Regular Interval Durvalumab 1500 mg every 4 weeks improved OS vs sorafenib in pts with unresectable HCC In Asian region HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib given concurrently with HAIC in pts with unresectable HCC
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None