RWE-BTC-ZANI
Research type
Research Study
Full title
Real-world Experience of Patients with Previously Treated Unresectable Locally Advanced or Metastatic HER2-positive (IHC3+) Biliary Tract Cancer Treated with Zanidatamab
IRAS ID
371652
Contact name
John Bridgewater
Contact email
Sponsor organisation
Jazz Pharmaceuticals UK Limited
Clinicaltrials.gov Identifier
73780, CPMS ID
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Biliary tract cancer (BTC) is a rare and aggressive group of cancers affecting the bile ducts (including intrahepatic, perihilar and distal cholangiocarcinoma) and the gallbladder. Many patients are diagnosed at an advanced stage when surgery is not possible, and despite existing treatments, outcomes remain poor. New therapies are therefore needed, particularly for patients whose cancer has progressed after standard treatments.
Zanidatamab is a medicine that targets HER2, a protein that is over‑expressed in some biliary tract cancers. Clinical trials have shown promising results and, prior to routine availability within the NHS, some patients in the UK received zanidatamab through an Early Access Programme (EAP). These programmes allow patients with serious conditions to receive potentially beneficial treatments while further evidence is being generated.
This research study will use existing medical records from UK patients who received zanidatamab via a more recent Early Access Programme. All patients included met current diagnostic criteria for HER2‑positive disease (defined as HER2 IHC3+). The study will collect real‑world data to better understand how zanidatamab is used and how patients respond to it in NHS clinical practice.
The study is retrospective and observational. It will not involve any changes to patient care, additional visits, tests, or treatments. Information will be taken only from medical records that were created as part of routine care. For living patients, an opt‑out approach will be used to allow individuals to decline use of their data if they wish.
The aims of the study are to describe the characteristics of patients treated with zanidatamab, how the treatment was used in practice, and outcomes such as how long patients remained on treatment and how their cancer progressed. The findings will help clinicians and researchers better understand the real‑world use of zanidatamab and may inform future care for patients with biliary tract cancer.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0209
Date of REC Opinion
16 Jun 2026
REC opinion
Favourable Opinion