Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375642
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-17
Brief Title:
A Single Arm Single Centered Phase II Trial on the Combination of Adebrelimab Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Single Arm Single Centered Phase II Trial on the Combination of Adebrelimab Surufatinib and Irinotecan Liposome-based Hepatic Artery Infusion Chemotherapy in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
Status:
NOT_YET_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:
Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide with limited treatment options and large unmet medical needs
Hepatic arterial infusion chemotherapy HAIC has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma HCC Increasing evidence suggests that infusion of HAIC which maintains high local concentrations of toxic agents in tumors without embolism provides a significant survival benefit for patients with advanced HCC and is well-tolerated However there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma
Irinotecan liposome nal-IRI is a concentrate of an infusion solution containing 5 mgml irinotecan trihydrate irinotecan sucrose salt active substance which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecanNal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma
AdebrelimaSHR-1316 is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 PD-L1 CD274 or B7-H1 a cell surface molecule that plays an important role in T cell immune function and stimulates IFN-γ secretion from mixed lymphocyte reactions MLRs of dendritic cells DCs and CD4 T cells
Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3 FGFR1 and CSF1R
This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma which may bring significant clinical benefit to the iCC patients with new treatment options
Hepatic arterial infusion chemotherapy HAIC has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma HCC Increasing evidence suggests that infusion of HAIC which maintains high local concentrations of toxic agents in tumors without embolism provides a significant survival benefit for patients with advanced HCC and is well-tolerated However there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma
Irinotecan liposome nal-IRI is a concentrate of an infusion solution containing 5 mgml irinotecan trihydrate irinotecan sucrose salt active substance which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecanNal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma
AdebrelimaSHR-1316 is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 PD-L1 CD274 or B7-H1 a cell surface molecule that plays an important role in T cell immune function and stimulates IFN-γ secretion from mixed lymphocyte reactions MLRs of dendritic cells DCs and CD4 T cells
Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3 FGFR1 and CSF1R
This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma which may bring significant clinical benefit to the iCC patients with new treatment options
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