Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
142actual
Sites
34
Countries
France, Germany, Italy +5
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-08-16 | actual | When the study began enrolling |
| Primary completion | 2025-10-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-17 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The 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
- Biological: Durvalumab — also filed as Background Gemcitabine-based Chemotherapy Regimen
- Drug: Gemcitabine monotherapy — also filed as Background Gemcitabine-based Chemotherapy Regimen
- Drug: Gemcitabine + cisplatin — also filed as Background Gemcitabine-based Chemotherapy Regimen
- Drug: Gemcitabine + oxaliplatin — also filed as Background Gemcitabine-based Chemotherapy Regimen
- Drug: Gemcitabine + carboplatin — also filed as Background Gemcitabine-based Chemotherapy Regimen
- Drug: Gemcitabine + cisplatin + S-1 — also filed as Background Gemcitabine-based Chemotherapy Regimen., This regimen is not allowed for countries in the European Union.
- Drug: Gemcitabine + S-1 — also filed as Background Gemcitabine-based Chemotherapy Regimen, This regimen is not allowed for countries in the European Union.
- Drug: Gemcitabine + cisplatin + albumin-bound paclitaxel — also filed as Background gemcitabine-based chemotherapy Regimen, This regimen is not allowed for countries in the European Union.
Primary outcome
what the primary-completion date above is the date OFNumber of participants with Grade 3 or 4 possibly related adverse event (PRAE)
measured Within 6 months after the initiation of Investigational Medicinal Product (IMP)
Publications
- PMID 42402265 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed