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Spots Global Cancer Trial Database for Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

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Trial Identification

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

Interventions

Pemigatinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Charité - Universitätsmedizin Berlin, Berlin, , Germany

Klinikum Esslingen, Esslingen, , Germany

Krankenhaus Nordwest, Frankfurt, , Germany

Klinikum Ludwigsburg, Ludwigsburg, , Germany

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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