Tasfygo for unresectable FGFR2‑fusion biliary tract cancer after chemotherapy
Official title: Post-marketing Observational Study of Tasfygo Tablet 35 mg to Evaluate the Safety of Tasfygo in Patients With Unresectable Biliary Tract Cancer With FGFR2 Fusion Gene Positivity Who Progressed After Chemotherapy
Run by Eisai Inc. · NCT06793709 · Data updated 2026-11-12
This study will see if Tasfygo is safe for people with unresectable biliary tract cancer who have an FGFR2 fusion and whose disease progressed after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | November 20, 2032 |
| Study ends | November 20, 2032 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06793709 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with unresectable biliary tract cancer that tests positive for FGFR2 fusion, who progressed after chemotherapy and have not previously taken Tasfygo tablets, are ideal candidates.
✕Probably not a fit
Patients without FGFR2 fusions, those who have already taken Tasfygo tablets, or those with resectable disease are unlikely to benefit from joining this observational safety study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This post-marketing observational study collects safety information on Tasfygo in patients with unresectable biliary tract cancer harboring FGFR2 fusions who progressed after prior chemotherapy. Participants who are naïve to Tasfygo tablets will be enrolled and followed at the sponsoring site for adverse events, laboratory results, and clinical outcomes as part of routine care. The study does not assign experimental interventions and treatment decisions are made by the treating physician. Data will be aggregated to characterize the real-world safety profile of Tasfygo in this population.
Why it matters
Potential benefit: If successful, the study could confirm Tasfygo's safety profile in this specific patient group and help clinicians use it more confidently after chemotherapy.
How similar studies have gone: Other FGFR2-targeted therapies, including futibatinib (marketed as Tasfygo), have shown clinical activity in FGFR2‑fusion biliary cancers, and post-marketing monitoring is commonly used to better define safety in broader populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: Not applicable.
Where it's running
-
#Eisai Trial Site 1
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Eisai Inquiry Service
- Email: eisai-chiken_hotline@hhc.eisai.co.jp
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.