Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-28 @ 5:06 AM
Study NCT ID:
NCT05913661
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Prospective, Single-arm, Multicenter Phase II Study of Evaluation of the Efficacy and Safety of Pemigatinib Combined With PD-1 Inhibitor in First-line Treatment of Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
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:
This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.
Detailed Description:
The study will be divided into two phases. The first phase is the safety import phase, in which three subjects with intrahepatic cholangiocarcinoma will be enrolled to receive a Scheduled dose of pemigatinib for one course of treatment， If the initial three subjects didn't develop DLT during the 21-day observation period, the dose will be considered tolerable and the study will proceed to Part II, otherwise, the dose will be adjusted and the evaluation will continue according to the above criteria.
A total of 30 subjects will be enrolled in Phase II of the study, and all screening-qualified subjects will receive pemigatinib combined with PD-1 inhibitor. pemigatinib and PD-1 inhibitors will be administered at established doses according to a regimen until progressive disease, intolerable toxicity, or informed consent form has been withdrawn. PD-1 inhibitors will be administered for a maximum of 24 months.
A total of 30 subjects will be enrolled in Phase II of the study, and all screening-qualified subjects will receive pemigatinib combined with PD-1 inhibitor. pemigatinib and PD-1 inhibitors will be administered at established doses according to a regimen until progressive disease, intolerable toxicity, or informed consent form has been withdrawn. PD-1 inhibitors will be administered for a maximum of 24 months.
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?: