Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505486
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hepatic Arterial Infusion of GEMOX Plus Systemic Gemcitabine Chemotherapy Combined With Lenvatinib and PD-1 Inhibitor in Large Unresectable Intrahepatic Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to preliminarily evaluate the clinical efficacy and safety of hepatic arterial infusion chemotherapy HAIC of gemcitabine and oxaliplatin GEMOX plus systemic gemcitabine chemotherapy GEM-SYS combined with lenvatinib and programmed cell death protein-1 PD-1 inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma uICC Large uICC patients who underwent GEMOX-HAIC Day 1 and GEM-SYS Day 8 3wcycle combined with lenvatinib and PD-1 inhibitor between November 2019 and December 2022 were enrolled Clinical data were retrospectively collected to analyze local tumor response progression-free survival PFS overall survival OS and adverse events AEs Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors RECIST version 11 AEs were evaluated by the common terminology criteria for adverse events CTCAE version 50 In this study OS was the primary endpoint and progression-free survival PFS was the secondary endpoint
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None