Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 1:30 AM
Study NCT ID:
NCT05174650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Study Overview
Official Title:
A Phase II Single-arm, Open-label Study of Atezolizumab and Derazantinib for Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
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:
The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
Detailed Description:
The aim of this phase II study is to explore the safety and anti-tumor efficacy of the combination of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma, with ORR as the primary endpoint.
The primary endpoint is the Objective Response Rate (ORR \[assessed every 8 weeks (±7 days)\]):
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment.
The secondary endpoints are safety and efficacy and will be evaluated by
* Incidence, treatment relationship, seriousness, and severity of all AEs, SAEs, AESIs according to CTCAE V5.0
* ORR@EOT:
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within study treatment.
• PFSR@6, 8 and 10 months: The proportion of patients known to be alive and without confirmed objective disease progression at 6, 8 and 10 months after first administration of study treatment, respectively.
• PFS: Time from first administration of study treatment until the date of first objective disease progression or death.
• OS: Time from first administration of study treatment until death of a patient due to any cause
The primary endpoint is the Objective Response Rate (ORR \[assessed every 8 weeks (±7 days)\]):
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment.
The secondary endpoints are safety and efficacy and will be evaluated by
* Incidence, treatment relationship, seriousness, and severity of all AEs, SAEs, AESIs according to CTCAE V5.0
* ORR@EOT:
Objective response rate (ORR) according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within study treatment.
• PFSR@6, 8 and 10 months: The proportion of patients known to be alive and without confirmed objective disease progression at 6, 8 and 10 months after first administration of study treatment, respectively.
• PFS: Time from first administration of study treatment until the date of first objective disease progression or death.
• OS: Time from first administration of study treatment until death of a patient due to any cause
Study Oversight
Has Oversight DMC:
False
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?: