Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04517227
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-05-03
First Post:
2020-08-14
Brief Title:
The Combination Therapy of TACE and Ablation With Durvalumab in Hepatocellular Carcinoma at Intermediate Stage TAD
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Single-Arm Open-Label Pilot Study of Combination Therapy of TACE and Ablation With Durvalumab in A Selected Hepatocellular Carcinoma Population at Intermediate Stage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
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 pilot study with a single arm in a single center assessing safety and efficacy of combination therapy of TACE and ablation and durvalumab This study will be conducted in selected patients with intermediate stage HCC not amenable to curative therapy
Detailed Description:
Approximately 30 patients will be enrolled and receive the following treatments
TACE day 1 up to twice TACE interval will be 46 weeks Ablation 4 weeks after the last TACE up to twice Ablation interval will be 46 weeks Durvalumab at least 1 week after the last ablation 1500 mg Q4W until mRECIST criteria defined radiological progression or other discontinuation criteria were met but no more than 1 year
TACE day 1 up to twice TACE interval will be 46 weeks Ablation 4 weeks after the last TACE up to twice Ablation interval will be 46 weeks Durvalumab at least 1 week after the last ablation 1500 mg Q4W until mRECIST criteria defined radiological progression or other discontinuation criteria were met but no more than 1 year
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