Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06109779

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Sponsor: AstraZeneca

Conditions Biliary Tract Cancer

Interventions Capecitabine Gemcitabine/Cisplatin Placebo Rilvegostomig S-1 [Tegafur/Oteracil/gimeracil]

Updated 22 times since 2023 Last updated: Mar 3, 2026 Started: Dec 4, 2023 Primary completion: Jan 2, 2029 Completion: May 3, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Biliary Tract Cancer and is currently ongoing. AstraZeneca leads this study, which shows 22 recorded versions since 2023 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

22 versions recorded

Mar 2026 — Present [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Dec 2025 — Mar 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE3
Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3

▶ Show 17 earlier versions

Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE3
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE3
May 2025 — Jun 2025 [monthly]

Recruiting PHASE3
Apr 2025 — May 2025 [monthly]

Recruiting PHASE3
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE3
Feb 2025 — Mar 2025 [monthly]

Recruiting PHASE3
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE3
Nov 2024 — Jan 2025 [monthly]

Recruiting PHASE3
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE3
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
May 2024 — Jul 2024 [monthly]

Recruiting PHASE3
Mar 2024 — May 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Nov 2023 — Jan 2024 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AstraZeneca

Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ankara, Turkey (Türkiye) , Antalya, Turkey (Türkiye) , Atlanta, United States , Aurora, United States , Barcelona, Spain , Beijing, China , Berlin, Germany , Birmingham, United States , Bonn, Germany , Brussels, Belgium and 142 more locations