Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572189
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
The Safety and Efficacy of CD-801 in Patients With Advanced Intrahepatic Cholangiocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Efficacy of Transarterial Injection of CD-801 in Patients With Advanced Intrahepatic Cholangiocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to learn about the safety of CD-801 a lipid nanoparticle-encapsulated self-replicating RNA encoding hepatocyte nuclear factor 4α HNF4α in treating patients with advanced intrahepatic cholangiocarcinoma ICC It will also learn if CD-801 works to treat advanced ICC The main questions it aims to answer are
1 What medical problems do participants have when injecting CD-801
2 Is CD-801 effective for ICC patients according to Response Evaluation Criteria in Solid Tumors RECIST version 11 or modified RECIST mRECIST
Participants will
Receive administration of 100μg of CD-801 via hepatic arterial injection every 14 3 days the dosing interval will be adjusted based on the tolerability safety and therapeutic effect of the subjects for one treatment cycle Treatment will continue until the occurrence of disease progression death intolerable toxicity voluntary withdrawal of informed consent loss to follow-up initiation of new antitumor treatment or termination of the study by the investigator whichever comes first and completion of the final follow-up and assessment 14 days after the last administration
1 What medical problems do participants have when injecting CD-801
2 Is CD-801 effective for ICC patients according to Response Evaluation Criteria in Solid Tumors RECIST version 11 or modified RECIST mRECIST
Participants will
Receive administration of 100μg of CD-801 via hepatic arterial injection every 14 3 days the dosing interval will be adjusted based on the tolerability safety and therapeutic effect of the subjects for one treatment cycle Treatment will continue until the occurrence of disease progression death intolerable toxicity voluntary withdrawal of informed consent loss to follow-up initiation of new antitumor treatment or termination of the study by the investigator whichever comes first and completion of the final follow-up and assessment 14 days after the last administration
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