RecruitingPHASE2INTERVENTIONAL

Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

This study is looking into a new treatment called ivonescimab for people with advanced bile duct cancer. It focuses on patients who have already had one type of chemotherapy that didn't stop their cancer from growing. Specifically, it's for those who were part of an earlier study (SAFIR-ABC10) but didn't receive an experimental drug at that time. The main goal is to find out if ivonescimab is better than the usual chemotherapy (called FOLFOX) for treating this type of cancer. Patients taking part will be randomly assigned to receive either ivonescimab or FOLFOX. The treatment will continue until the cancer starts to grow again, or for a maximum of about two years for ivonescimab, whichever comes first.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

UNICANCER

Enrolment target

Start

09 Oct 2025

Estimated completion

30 Jan 2029

Biliary Tract Cancer

What is this study about?

This study is for people with advanced bile duct cancer, a type of cancer that affects the tubes carrying bile from the liver. When cancer is advanced, it means it has spread or can't be removed with surgery. We want to find out if a new medicine, ivonescimab, is more effective than the standard chemotherapy treatment called FOLFOX.

This is a 'Phase 2' study, which means we're still in the earlier stages of testing this new treatment. The main aim is to see how well ivonescimab works compared to FOLFOX and if it's safe to use. You might be eligible if your cancer has grown despite having received standard chemotherapy already, and if you were part of a previous study called SAFIR-ABC10 but didn't get the experimental treatment then.

By comparing ivonescimab to FOLFOX, we hope to discover if this new treatment could offer a better option for people living with advanced bile duct cancer. Your participation could help us learn more and potentially lead to new and improved ways to treat this condition in the future.

Key takeaways

This study compares a new drug (ivonescimab) to standard chemotherapy (FOLFOX) for advanced bile duct cancer.
It's for people whose cancer has progressed after initial chemotherapy and who previously screened for the SAFIR-ABC10 study.
You'll be randomly assigned to get either ivonescimab or FOLFOX.
Treatment continues until the cancer grows or for a maximum of about two years for ivonescimab.
Regular scans and health checks will monitor your progress and well-being.

Who may be eligible?

This study is for adults aged 18 or over. To be considered, you must have been diagnosed with a specific type of bile duct cancer (either inside the liver, near the liver, or in the gallbladder – but not ampullary cancer). Your cancer needs to be advanced, meaning it cannot be removed by surgery or has spread to other parts of the body.

Importantly, you must have already taken part in the initial screening stage of a previous study called SAFIR-ABC10. Your cancer must also have gotten worse after your first course of standard chemotherapy (like CISGEM). You'll also need to be well enough to receive treatment, which doctors will check using a standard health assessment. Your organs, like your liver, kidneys, and blood, will need to be working well enough for you to safely join the study.

Finally, doctors will need to be able to see at least one part of your cancer clearly on scans to measure how it responds to treatment.

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.

Are you 18 years old or older?
Do you have a specific type of advanced bile duct cancer (not ampullary)?
Has your cancer grown after your first chemotherapy treatment?
Did you previously take part in the screening part of the SAFIR-ABC10 study?
Are you generally well enough to receive treatment, as judged by your doctor?
Are your liver, kidney, blood, and heart functions generally good?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first sign a consent form and have several health checks to make sure you're suitable. Once confirmed, you'll be randomly assigned to one of two groups: two out of three people will receive the new medicine, ivonescimab, and one out of three will receive the standard chemotherapy, FOLFOX. This is done by chance, like flipping a coin, to ensure a fair comparison.

Both treatments are given through a drip into your vein. Ivonescimab is given once every three weeks. FOLFOX is given according to its standard schedule. You will continue your assigned treatment until your cancer starts to grow again, or for up to about two years if you are on ivonescimab, whichever happens first.

During the study, you will have regular scans, usually every six weeks, to check how your cancer is responding to the treatment. You will also have regular blood tests and other health checks to monitor your well-being and any side effects. The total length of your participation will depend on how your cancer responds to treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment (ivonescimab) that might be more effective than standard chemotherapy, or receiving standard treatment with close monitoring. However, there are potential risks. Both ivonescimab and FOLFOX can cause side effects, which your medical team will discuss with you. These side effects can vary from mild to severe, and some might be serious. Before joining, you'll receive detailed information about all known risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting
Institut de cancerologie de l'Ouest - Angers
Verified postcode
Angers, France· Not yet recruiting
Institut du Cancer Avignon Provence
Verified postcode
Avignon, France· Recruiting
CHU Besançon
Verified postcode
Besançon, France· Not yet recruiting
CHU de Bordeaux - Hôpital Haut-Leveque
Verified postcode
Bordeaux, France· Not yet recruiting
Centre François Baclesse
Verified postcode
Caen, France· Not yet recruiting
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Estaing de Clermont Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
APHP - Hôpital Beaujon
Verified postcode
Clichy, France· Recruiting
APHP - Hopital Henri Mondor
Verified postcode
Créteil, France· Not yet recruiting
CHU de Dijon
Verified postcode
Dijon, France· Recruiting
Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard
Verified postcode
Grenoble, France· Recruiting

Common questions

What is bile duct cancer?

Bile duct cancer is a type of cancer that starts in the small tubes (bile ducts) that carry bile from the liver to the small intestine.

What does 'advanced' cancer mean?

Advanced cancer means the cancer has either spread to other parts of the body or cannot be completely removed by surgery.

What is ivonescimab?

Ivonescimab is a new medicine being tested to see if it can help treat advanced bile duct cancer.

What is FOLFOX?

FOLFOX is a standard chemotherapy treatment that is commonly used for certain types of cancer, including some advanced bile duct cancers. It's a combination of different chemotherapy drugs.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know whether you are receiving ivonescimab or FOLFOX.

How to find out more

Daniel Couch

d-couch@unicancer.fr +33 (0)1 80 50 12 96 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.