Recruiting PHASE3 INTERVENTIONAL 2-arm NCT05615818

Personalized Medicine for Advanced Biliary Cancer Patients (SAFIR-ABC10)

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

Sponsor: Accord Healthcare, Inc.

Conditions Biliary Tract Neoplasms

Interventions Binimetinib Cisplatin Encorafenib Futibatinib Gemcitabine Ivosidenib Neratinib Niraparib Trastuzumab Zanidatamab

Updated 14 times since 2022 Last updated: Apr 22, 2025 Started: Jul 18, 2024 Primary completion: Jun 30, 2027 Completion: Jun 30, 2028

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

A PHASE3 clinical study on Biliary Tract Neoplasms, this trial is actively recruiting participants. The trial is conducted by Accord Healthcare, Inc. and has accumulated 14 data snapshots since 2024. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Recruiting PHASE3
May 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Apr 2025 — May 2025 [monthly]

Recruiting PHASE3
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE3
Dec 2024 — Mar 2025 [monthly]

Recruiting PHASE3

▶ Show 9 earlier versions

Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
May 2024 — Jul 2024 [monthly]

Not Yet Recruiting PHASE3
Feb 2024 — May 2024 [monthly]

Not Yet Recruiting PHASE3
Dec 2023 — Feb 2024 [monthly]

Not Yet Recruiting PHASE3
Sep 2023 — Dec 2023 [monthly]

Not Yet Recruiting PHASE3
Apr 2023 — Sep 2023 [monthly]

Not Yet Recruiting PHASE3
Dec 2022 — Apr 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Accord Healthcare, Inc.
Belgian Group of Digestive Oncology
Cancer Research UK
Cancer Research UK & UCL Cancer Trials Centre
National Cancer Institute, France
Pierre Fabre Medicament
Servier
Taiho Oncology, Inc.
UNICANCER
Zymeworks BC Inc.

Data source: UNICANCER

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

Study Locations

Amiens, France , Angers, France , Avignon, France , Besançon, France , Birmingham, United Kingdom , Bordeaux, France , Bristol, United Kingdom , Brussels, Belgium , Caen, France , Cambridge, United Kingdom and 40 more locations