Clinical Trials Logo
  1. Home
  2. Intrahepatic Cholangiocarcinoma
  3. NCT05174650

Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:
A Phase II Single-arm, Open-label Study of Atezolizumab and Derazantinib for Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05174650
Study type Interventional
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact Arndt Vogel, Prof. Dr.
Phone +49 176 1 532 9590
Email vogela@me.com
Status Recruiting
Phase Phase 2
Start date April 20, 2022
Completion date August 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Completed NCT01938729 - Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma Phase 1
Completed NCT03230318 - Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT06239532 - HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05535647 - Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05009953 - Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT02254681 - Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC Phase 2
Active, not recruiting NCT01954745 - A Phase II Study of Cabozantinib (XL-184) Monotherapy in Patients With Advanced Cholangiocarcinoma After Progression on First or Second Line Systemic Therapy Phase 2
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05285358 - Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases Phase 1
Completed NCT03320980 - RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma N/A
Withdrawn NCT05019677 - GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC Phase 2
Withdrawn NCT03801499 - Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT05489692 - HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Recruiting NCT06101277 - Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG) N/A
Active, not recruiting NCT01917370 - VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway N/A
Withdrawn NCT01775280 - Response of Hepatic Tumors to Radioembolization Phase 2
Not yet recruiting NCT05342194 - Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Phase 3