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An Observational Study for Investigating the Frequency of FGFR2 Gene Fusion in Unresectable Advanced or Metastatic Cholangiocarcinomasaddddddc

An Observational Study for Investigating the Frequency of FGFR2 Gene Fusion in Unresectable Advanced or Metastatic Cholangiocarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080225086
Enrollment
550
Registered
2020-02-25
Start date
2020-01-31
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

CholangiocarcinomaCholangiocarcinoma

Interventions

Sponsors

Eisai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Provide written informed consent 2.Male or female subjects age >= 20 years at the time of informed consent 3.Subjects with a histologically or cytologically diagnosis of intrahepatic or perihilar cholangiocarcinoma 4.Subjects with surgically unresectable or advanced/metastatic disease 5.Subjects with Performance Status (PS) score of 0 1 established by Eastern Cooperative Oncology Group (ECOG) 6.Subjects who are expected to survive for 3 months or longer after Informed consent.

Exclusion criteria

Exclusion criteria: 1. History of active malignancy (except for primary tumor or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix, or early stage colorectal cancer) within the past 24 months prior to informed consent 2. Patients with prior therapy targeting FGFR2 3. Any subjects who are judged by the principal investigator or sub-investigators to be inappropriate as subjects in this study

Design outcomes

Primary

MeasureTime frame
exploratory Frequency of FGFR2 Gene Fusion

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026