Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04996446
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2021-08-04
Brief Title:
ALPPS Combined With Tislelizumab in Liver Malignancy
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Safety and Efficacy of the Combinationg of Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy ALPPS and Tislelizumab in Liver Malignancy
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
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:
Study design Prospective single-center phase IIa clinical trial Primary endpoint Recurrence free survival Secondary endpoints Safety overall survival Main characteristics of patients Liver malignancy required extended hemihepatectomy insufficient liver reserve Study approaches The experimental group is treated with ALPPS combined with Tislelizumab and the control group was treated with ALPPS Sample size 20 1010 Study process In experimental group patients who meet the inclusion criteria will receive ALPPS stage I surgery treated with Tislelizumab 2-4 weeks after stage I surgery and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment and treated with Tislelizumab q3W 6-12 months after stage II surgery In control group patients who meet the inclusion criteria will receive ALPPS stage I surgery and receive ALPPS stage II surgery 3-6 weeks after stage I surgery
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?:
None
Is an FDA AA801 Violation?:
None