Not yet recruitingPHASE2INTERVENTIONAL

Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

This study is for people with advanced bowel (colorectal) cancer that has spread (metastatic) and has not responded to previous treatment. The usual second treatment often involves chemotherapy with a drug that stops blood vessel growth in tumours. This study wants to see if a new drug, Fruquintinib, which also works by stopping blood vessel growth, is a safe and effective option when combined with standard chemotherapy (FOLFOX or FOLFIRI). Researchers will compare this new combination to the standard treatment of chemotherapy with another drug called Bevacizumab. The aim is to find better ways to treat this type of cancer.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Federation Francophone de Cancerologie Digestive

Enrolment target

Start

31 Dec 2025

Estimated completion

31 Oct 2028

Metastatic Colorectal Carcinoma (mCRC)

What is this study about?

This study, called ULYSSE, is looking at a type of bowel cancer that has spread to other parts of the body, known as metastatic colorectal cancer. Once the initial treatment for this cancer hasn't worked as well as hoped, doctors often move to a second type of treatment. This usually involves chemotherapy combined with another drug that works by blocking a substance called VEGF, which helps tumours grow new blood vessels.

Currently, common drugs used for this purpose are Bevacizumab or Aflibercept. The ULYSSE study is investigating a newer drug called Fruquintinib.fruquintinib also works by blocking VEGF, aiming to stop blood vessels from forming and feeding the tumour. The main goal is to find out if Fruquintinib, when added to standard chemotherapy (either FOLFOX or FOLFIRI), is as good or even better and safer than the current standard treatment of chemotherapy plus Bevacizumab.

By comparing these two treatment approaches, researchers hope to discover if Fruquintinib could offer a new and effective option for patients whose cancer has specific characteristics (known as BRAF wild-type and MSS). This is important because it could lead to more treatment choices and potentially better outcomes for people living with advanced bowel cancer.

Key takeaways

This study compares a new and an existing treatment for advanced bowel cancer.
It aims to find better ways to treat metastatic colorectal cancer.
The new drug, Fruquintinib, works by stopping tumour blood vessel growth.
Participants will receive either Fruquintinib with chemotherapy or Bevacizumab with chemotherapy.
Rigorous health checks and monitoring are a key part of participating.

Who may be eligible?

To be able to join this study, there are certain requirements you would need to meet. You must be between 18 and 80 years old. If you're 75 or older, you'll have to complete a special questionnaire about your general health with a good score. You must have bowel cancer that has spread and has been confirmed by a doctor, and your cancer must have grown even after your first round of treatment.

Your cancer must also be in a place where surgery or other local treatments aren't possible at the time you join the study. Doctors will need to be able to measure at least one of your cancer spots on scans. Your general health should be good enough for you to go about your daily activities with little or no difficulty. Your liver, kidney, and blood test results also need to be within a healthy range.

If you are a woman who could become pregnant, you must agree to use effective birth control during and for 15 months after the study. If you are a man having sex with a woman who could become pregnant, you must also use birth control during and for 12 months after the study.

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 between 18 and 80 years old?
Do you have bowel cancer that has spread and already had some treatment for it?
Do your doctors say your cancer spots cannot be surgically removed or treated locally?
Is your general health good enough for daily activities with little to no help?
Are your recent blood tests (for liver, kidney, and blood count) within healthy limits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either chemotherapy (FOLFOX or FOLFIRI) plus Fruquintinib, or chemotherapy plus Bevacizumab. Both chemotherapy combinations are given intravenously (into a vein). The study will involve regular hospital visits for your treatments, blood tests, and scans to check how you are responding and for any side effects. The exact number of visits and tests will be explained by the study team.

Throughout the study, you will have specialist medical supervision. After your treatment phase is complete, there will be a follow-up period to monitor your health and any long-term effects. The total duration of your participation, including follow-up, will be discussed in detail by the study team, but generally these types of studies can last for many months to a few years.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and innovative treatment (Fruquintinib) that may be more effective than existing options, or receiving standard care with close monitoring. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy, Fruquintinib, and Bevacizumab, which the study doctors will explain in full. You will be closely monitored for any reactions, and your safety is a top priority. Remember, participating in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (45)

ICO Site Paul Papin
Verified postcode
Angers, France
Les Bonnettes
Verified postcode
Arras, France
Ght Unyon Auxerre
Verified postcode
Auxerre, France
Bayeux Ch
Verified postcode
Bayeux, France
Cote Basque
Verified postcode
Bayonne, France
Beauvais Ch
Verified postcode
Beauvais, France
Jean Minjoz
Verified postcode
Besançon, France
Centre Pierre Curie
Verified postcode
Beuvry, France
BERGONIÉ
Verified postcode
Bordeaux, France
TIVOLI
Verified postcode
Bordeaux, France
Chauny Ch
Verified postcode
Chauny, France
Cholet Ch
Verified postcode
Cholet, France

Common questions

What is metastatic colorectal cancer?

It's a type of bowel cancer that has spread from where it started to other parts of your body.

What is Fruquintinib and how does it work?

Fruquintinib is a new drug designed to stop tumours from growing new blood vessels, which they need to get nutrients and grow.

What is Bevacizumab?

Bevacizumab is a standard drug that also works by stopping blood vessel growth in tumours, similar to Fruquintinib.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one treatment group or the other, and you might not know which specific drug you are receiving until the study is over, or if medically necessary.

What are FOLFOX and FOLFIRI?

These are common types of chemotherapy drug combinations used to treat bowel cancer.

How to find out more

Sofia BOUHLAL JOURDAN, PhD

prodige115.ulysse@ffcd.fr +33(0)7 55 67 67 95 Official trial record

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