Real-world outcomes of patients with HER2-positive biliary tract cancer treated with zanidatamab through an Early Access Programme
Biliary tract cancer affects the gallbladder and bile ducts. It is often found at an advanced stage when treatment choices are limited. Some people have a type of cancer that produces too much of a protein called HER2. Before a targeted drug called zanidatamab became widely available, some patients received it through a special Early Access Programme. This observational study looks at existing medical records from patients in the UK, Spain, and Italy who had this treatment. Researchers want to understand how zanidatamab worked in everyday hospital care, rather than in a rigid trial setting. Taking part does not require any extra appointments, scans, or blood tests. Instead, researchers securely review past medical charts. The findings will help doctors learn more about the medicine's real-world benefits and guide care for future patients.
At a glance
What is this study about?
Biliary tract cancer is an uncommon cancer that develops in the gallbladder or the small tubes that carry bile to the digestive system. Because early symptoms can be subtle, many people find out they have it after the cancer has already spread. In some cases, the tumour cells produce high amounts of a specific protein known as HER2. This protein acts like an accelerator pedal, causing the cancer cells to grow and divide.
Zanidatamab is a targeted medicine designed to lock onto HER2 proteins and slow or stop cancer growth. Before this medicine was officially licensed or widely funded, some patients in the UK, Spain, and Italy were able to receive it through an Early Access Programme. This scheme allowed people with advanced cancer to try a promising therapy when standard options were no longer working.
Standard clinical trials test drugs under very strict conditions, which may not always reflect everyday life. This study, called RealiZe, looks back at routine hospital records to see what happened when patients received zanidatamab in real-world clinical care. Researchers will check how tumours responded, how long the benefits lasted, and what treatments were given next.
Understanding real-world results helps doctors and healthcare services see how a medicine performs across a broader range of patients. The insights gained from this study could help doctors make more informed treatment decisions for people diagnosed with HER2-positive biliary tract cancer in the future.
Key takeaways
- This is an observational study reviewing existing hospital notes, not a trial of a new drug.
- It evaluates real-world outcomes of the targeted therapy zanidatamab in adults with HER2-positive biliary tract cancer.
- Participants must have already received zanidatamab through an Early Access Programme in the UK, Spain, or Italy.
- There are no extra clinic visits, blood tests, scans, or changes to your daily care.
- Data is kept confidential, and UK patients can opt out through the NHS at any time.
Who may be eligible?
This study looks at adults aged 18 and over who have advanced or metastatic HER2-positive biliary tract cancer that could not be removed with surgery. To be considered, you must have already received prior cancer therapy and had at least one dose of zanidatamab through the Early Access Programme in the UK, Spain, or Italy.
In the UK, eligible patients are identified through their hospital records using an approved opt-out system. You will not be included if you have registered with the NHS National Data Opt-Out service or if you tell your care team that you do not want your records used for research.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with HER2-positive bile duct or gallbladder cancer.
- My cancer is advanced or cannot be removed with surgery.
- I received at least one dose of zanidatamab through the Early Access Programme.
- I have not opted out of NHS health research (or I have given consent if living in Spain or Italy).
What does participation involve?
Taking part in this study does not require any active effort from you. There are no clinic visits, no blood tests, and no questionnaires to fill in. You will not be asked to start or stop any medications. Researchers will simply look back at data already recorded in your hospital notes. They will gather details such as your age, past treatments, how your tumour responded to zanidatamab, and how you felt during care. The study collects this information between August 2026 and October 2026. Because it is a review of past notes, your ongoing medical care will not change in any way.
Potential risks and benefits
Locations (7)
- University College London Hospitals NHS Foundation TrustCity onlyLondon, England
- Humanitas Cancer Center – IRCCS Humanitas Research HospitalCity onlyRozzano (Milan), Italy
- IRCCS Candiolo Cancer InstituteApproximateCandiolo (Turin), Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori di MilanoCity onlyMilan, Italy
- Hospital Universitario Fundación Jiménez DíazCity onlyMadrid, Spain
- Vall d'Hebron Institute of OncologyUnverifiedBarcelona, Spain
- Hospital Universitario 12 de OctubreUnverifiedMadrid, Spain
Common questions
Will I need to take a new medicine for this study?
No. This study only looks at records of treatment you have already had in the past through the Early Access Programme.
Do I have to travel to extra hospital appointments?
No. Researchers only review your existing medical notes, so you will not need to attend any extra visits, scans, or check-ups.
How is my personal medical information kept safe?
Your personal details, such as your name and contact information, are replaced with a secure code. Only de-identified data is shared with the study team.
What was the Early Access Programme?
It was a programme that gave patients access to zanidatamab before it was officially licensed, offering an option when standard treatments had already been tried.
Can I stop my information from being used?
Yes. If you live in the UK, you can use the NHS National Data Opt-Out or tell your doctor that you do not want your records shared for research.
How to find out more
Sophie Thornton
Always speak to your GP or specialist before deciding to take part in a study.
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