Clinical Trials Logo
  1. Home
  2. Intrahepatic Cholangiocarcinoma
  3. NCT05565794

Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:
A Phase II Study of Pemigatinib After Curative Local Therapy in Locally Advanced Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Fusions/Rearrangements.

Clinical Trial Summary

The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the safety profile to support the continuation of the concept in a large, randomized trial for further development.

Clinical Trial Description

This is a prospective, exploratory, single-arm, non-randomized, open-label phase II study to investigate whether pemigatinib is clinically efficacious after curative local treatment including surgery/ SBRT or ablation in iCCA patients with FGFR2 fusion/rearrangements. Patients will receive pemigatinib 13.5 mg oral once daily (21-day cycle; two weeks on, one week off) until disease recurrence, unacceptable toxicity, withdrawal of consent, or investigator decision, but no longer than 12 months (max. 18 cycles). The primary objective is to assess the efficacy of pemigatinib administered after curative local therapy in treatment-naïve patients with resectable intrahepatic biliary tract cancer (recurrence free survival rate at 12 months, RFS@12). Secondary objectives are to assess the efficacy by overall survival (OS) and recurrence free survival (RFS); to assess safety of the treatment (AEs, impact on liver function, use of subsequent therapies); to assess quality of life (QoL). In addition, tissue samples will be analyzed for biomarkers predictive for RFS and OS. 20 patients are to be enrolled in this trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05565794
Study type Interventional
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact Thorsten Goetze, Prof. Dr.
Phone +49 69 7601 4187
Email goetze.thorsten@khnw.de
Status Recruiting
Phase Phase 2
Start date November 11, 2022
Completion date November 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