Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements
NCT05174650 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2025-12-05
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
Conditions
- Intrahepatic Cholangiocarcinoma
Interventions
- DRUG
-
Infusion i.v. of atezolizumab on day 1 of a 3-week cycle, first infusion rate over 60 minutes, subsequent infusion rates 30 minutes if tolerated for a maximum of 20 cycles in total
- DRUG
-
Derazantinib
Oral intake of 300 mg derazantinib continuously on day 1 to day 21 of a 3-week cycle for a maximum of 20 cycles in total
Sponsors & Collaborators
-
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-20
- Primary Completion
- 2025-12-31
- Completion
- 2026-08-31
Countries
- Germany
Study Locations
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