PEARLDIFER - A Phase II study of pemigatinib after curative local therapy in locally advanced intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512018-16-00

Acronym

PEARLDIFER

Enrollment

Registered

2024-08-19

Start date

2022-11-11

Completion date

2025-03-27

Last updated

2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements

Brief summary

Recurrence free survival rate at 12 months (RFS@12)

Detailed description

Incidence, treatment relationship, seriousness, and severity of all AEs, SAEs according to CTCAE V5.0, Overall survival (OS), Recurrence free survival (RFS), Effect of therapy on global health status/quality of life and on other symptoms and scales of the EORTC-QLQ-C30, EORTC-QLQ-BIL21 and EQ-5D-5L after 6 and 12 months (proportion of patients with a better, stable, or worse score)

Interventions

DRUGPemazyre 4.5 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence free survival rate at 12 months (RFS@12)	—

Secondary

Measure	Time frame
Incidence, treatment relationship, seriousness, and severity of all AEs, SAEs according to CTCAE V5.0, Overall survival (OS), Recurrence free survival (RFS), Effect of therapy on global health status/quality of life and on other symptoms and scales of the EORTC-QLQ-C30, EORTC-QLQ-BIL21 and EQ-5D-5L after 6 and 12 months (proportion of patients with a better, stable, or worse score)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026