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Brief Title: Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements
Official Title: A Phase II Study of Pemigatinib After Curative Local Therapy in Locally Advanced Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Fusions/Rearrangements.
Study ID: NCT05565794
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Klinikum Esslingen, Esslingen, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Name: Thorsten Goetze, Prof. Dr.
Affiliation: Krankenhaus Nordwest, Frankfurt
Role: PRINCIPAL_INVESTIGATOR
Name: Salah-Eddin Al-Batran, Prof. Dr.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH
Role: STUDY_DIRECTOR