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RecruitingNCT06793709Updated Feb 27, 2026

A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy

An observational study in Biliary Tract Cancer, sponsored by Eisai Co., Ltd.. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Eisai Co., Ltd. · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study summary

The primary purpose of this study is to investigate the safety of Tasfygo.

02

Conditions studied

  • Biliary Tract Cancer

Keywords

  • Tasfygo
  • FGFR2 fusion
  • Cancer
03

In context

Biliary Tract Neoplasms

519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.

This study's planned enrollment of 60 is below the median of 160 across 73 observational studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants with FGFR2 fusion positive unresectable biliary tract cancer with prior chemotherapy who will receive Tasfygo tablet as per daily practice and package insert will be enrolled.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.

Exclusion criteria

Exclusion Criteria:

Not applicable.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Tasfygo tablet 35 milligrams (mg)

    Other: No Intervention

Interventions

  • OtherNo Intervention

    This is a non-interventional study.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Drug Reactions

    Time frame: Up to 1 year

Secondary outcomes

  1. Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment

    Time frame: Up to 1 year

07

Study locations

1 of 1 sites recruiting
  • #Eisai Trial Site 1
    Tokyo, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06793709
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Jan 27, 2025
Start date
Jul 10, 2025
Primary completion
Nov 20, 2032 (estimated)
Completion
Nov 20, 2032 (estimated)
Last update
Feb 27, 2026

Study contacts

Eisai Inquiry Service
Contact
eisai-chiken_hotline@hhc.eisai.co.jp

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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