Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298968
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-01
Brief Title:
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma a Prospective Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
In this phase 2 study the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma
Detailed Description:
Most intrahepatic cholangiocarcinoma ICC patients are often accompanied by local or distant metastases and lose the opportunity for surgical resection For patients with unresectable ICC who have been in stages IIIb and IV AJCCUICC V2 2018 the survival time is less than 4 months and there is currently no standard treatment TheGC chemotherapy gemcitabine and cisplatin has been used in the treatment of advanced intrahepatic cholangiocarcinoma but the efficacy is still unsatisfactory Lenvatinib is a small molecule multi-kinase inhibitor the main targets including VEGFR1-3 fibroblast growth factor receptor 1-4 PDGFRα RETret proto-oncogene KITKIT proto-oncogene receptor tyrosine kinase have anti-angiogenic effects have been proven effective in hepatocellular carcinoma In recent years immunological checkpoint inhibitors ICIs have shown remarkable therapeutic effects in the treatment of various solid tumors Combined with other therapies such as chemotherapy and targeted drugs is an important direction to improve the therapeutic effect of immunological checkpoint inhibitors In this study the investigators aim to evaluate the efficacy and safety of GC chemotherapy combined with Lenvatinib and immune checkpoint inhibitor PD-L1 antibody Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma
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