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Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

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NCT06109779 · readout in 867 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
760actual
Sites
177
Countries
Australia, Belgium, Brazil +18

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-12-04actualWhen the study began enrolling
Primary completion2029-01-02estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2030-05-03estimatedThe whole study's end, after follow-up
First posted2023-10-31actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-10actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Biliary Tract Cancer

Interventions

  • Drug: Rilvegostomig
  • Drug: Placebo
  • Drug: Capecitabine
  • Drug: Gemcitabine/Cisplatin
  • Drug: S-1 [Tegafur/Oteracil/gimeracil]

Primary outcome

what the primary-completion date above is the date OF
Recurrence free survival (RFS) for Arm A vs. Arm B
measured Approximately 5 years

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