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

Not Applicable

Completed

• Conditions: CholangiocarcinomaCholangiocarcinoma

• Registration Number: JPRN-jRCT1080225086
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-25
• Study Completion: 2022-07-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 550

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified