A multicenter open-label randomized controlled prospective phase II study evaluating the efficacy of Selective Internal Radiation Therapy (Yttrium-90 glass microspheres) combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516683-29-00

Acronym

2017-02-32-005

Enrollment

Registered

2024-08-23

Start date

2022-02-04

Completion date

Unknown

Last updated

2025-05-13

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

Conditions

Biliary tract cancer

Brief summary

Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm, Frequency of subjects actually resected, Frequency of subjects with R0 and R1 resection, Frequency of subjects with an observed objective response, Mean percentage of tissue with necrosis in resected specimen, Disease-Free survival, Overall survival

Interventions

DRUGCapecitabine Accord 500 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm, Frequency of subjects actually resected, Frequency of subjects with R0 and R1 resection, Frequency of subjects with an observed objective response, Mean percentage of tissue with necrosis in resected specimen, Disease-Free survival, Overall survival	—

Countries

France

Outcome results

None listed

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