Real-world outcomes of patients with HER2-positive biliary tract cancer treated with zanidatamab through an Early Access Programme

1. Approved 23/03/2026, Health and Social Care Research Ethics Committee B (HSC REC B) (Office for Research Ethics Committees Northern Ireland (ORECNI), 2nd Floor James House, 2-4 Cromac Avenue, BELFAST, BT7 2JA, United Kingdom; +44 (0)28 95 361400; PRS@hscni.net), ref: 26/NI/0041

2. Approved 26/04/2026, Comité de Ética de la Investigación de la Fundación Jiménez Díaz (CEIm) (C/ del Maestro Ángel Llorca, 6, Bajo B, Edificio Alto, Madrid, 28003, Spain; +34 (0)91 544 37 20; ceic@fjd.es), ref: EO093-26_FJD

3. Submitted 14/07/2026, Comitato Etico Territoriale Lombardia 5 (Via Alessandro Manzoni 56, Rozzano (MI), 20089, Italy; +39 (0)2 8224 7216; cetlombardia5@humanitas.it), ref: 436/26

1. Real-world time on treatment (rwToT) measured using the time from zanidatamab treatment initiation to treatment discontinuation for any reason, including physician-assessed disease progression, treatment-related toxicity, clinical decision, or death, derived from patient medical records and recorded in the electronic case report form (eCRF) at the end of the available follow-up
2. Real-world progression-free survival (rwPFS) measured using the time from zanidatamab treatment initiation to physician-assessed disease progression or death from any cause, whichever occurs first, derived from patient medical records and recorded in the eCRF at the end of the available follow-up
3. Real-world subsequent-line progression-free survival (rwPFS2) measured using the time from zanidatamab treatment initiation to physician-assessed disease progression following subsequent-line treatment or death from any cause, whichever occurs first, derived from patient medical records and recorded in the eCRF at the end of the available follow-up
4. Real-world overall survival (rwOS) measured using the time from zanidatamab treatment initiation to death from any cause, derived from patient medical records and recorded in the eCRF at the end of the available follow-up
5. Real-world duration of response (rwDOR) measured using the time from first documented physician-assessed partial response or complete response to disease progression or death, derived from patient medical records and recorded in the eCRF at the end of the available follow-up
6. Real-world objective response rate (rwORR) measured using the proportion of patients achieving a physician-assessed complete response or partial response to zanidatamab treatment, based on medical record review and recorded in the eCRF at the end of the available follow-up

1. Patient demographics and relevant medical history measured using demographic and clinical characteristics abstracted from medical records, including country of treatment, age at zanidatamab initiation, sex at birth, relevant comorbidities, date of biliary tract cancer diagnosis, HER2 test results, previous surgery, biliary tract cancer subtype, previous lines of treatment, ECOG performance status and participation in other interventional clinical trials at baseline (zanidatamab treatment initiation)
2. Dates of zanidatamab treatment initiation and discontinuation measured using patient medical records and recorded in the eCRF at the end of the available follow-up
3. Zanidatamab dose, dose modifications and treatment interruptions measured using patient medical records and recorded in the eCRF at the end of the available follow-up