Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04527679
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2020-08-23
Brief Title:
Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Combined Therapy Using Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma a Single-arm Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_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:
We aim to explore the effects and safety of GC Cisplatin and gemcitabine chemotherapy combined with Lenvatinib as first-line therapy in advanced or unresectable intrahepatic cholangiocarcinoma
Detailed Description:
For advanced intrahepatic cholangiocarcinoma ICC that cannot be surgically removed or accompanied by metastasis the NCCN guidelines NCCN guidelines hepatobiliary cancer 2019 recommend that the current treatment options are limited mainly recommending gemcitabine combined with platinum based antitumor drugs cisplatin oxaliplatin etc chemotherapy as first-line treatment Adding targeted drugs can enhance the anti-tumor effect GC chemotherapy Cisplatin gemcitabine has been used in the treatment of advanced intrahepatic cholangiocarcinoma but the efficacy is still not satisfactory Lenvatinib is a small-molecule multikinase inhibitor that is currently approved for first-line treatment of advanced hepatocellular carcinoma Lenvatinib combined with chemotherapy may have a better effect than single use for advanced ICC At present lenvatinib combined with GC chemotherapy in the first-line treatment of advanced ICC has not been reported
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