Active not recruitingPHASE3INTERVENTIONAL

Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

This research is looking at a new way to treat advanced bowel cancer (metastatic colorectal cancer) when other standard treatments have stopped working. The study is comparing a new drug combination – Regorafenib and Irinotecan – against Regorafenib given alone. Both drugs are already used to treat cancer. Researchers want to see if combining them gives patients a better outcome. The study focuses on patients whose cancer has grown even after receiving multiple previous treatments, including chemotherapy and targeted therapies. It's a phase 3 study, meaning it's a larger trial to confirm if the new combination is more effective or safer than current approaches.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

377

Start

28 Mar 2019

Estimated completion

01 Sep 2026

Metastatic Colorectal Cancer (mCRC)

Results

Results from this study

Posted July 2025

Results have been published for this study.

Primary outcome

Overall Survival

Full results on the registry

What is this study about?

This study is for people in the UK living with advanced bowel cancer (also called metastatic colorectal cancer). This is when the cancer has spread from the bowel to other parts of the body. Unfortunately, for some patients, standard treatments, such as chemotherapy and other targeted drugs, eventually stop working.

When this happens, there are often very few treatment choices left. This study aims to find a new option for these patients. It's testing whether combining two existing cancer drugs, Regorafenib and Irinotecan, could be more effective than Regorafenib given on its own. Regorafenib is already used to treat advanced bowel cancer in people who have had a lot of previous treatments.

Researchers previously looked at a similar drug, Sorafenib, in combination with Irinotecan. They believe that Regorafenib, which is very similar to Sorafenib, might work well in the same combination. This study is a ‘Phase 3’ trial, which means it's a large, important study designed to confirm if this new combination is a better treatment option for patients whose cancer has progressed after many previous therapies.

Key takeaways

It's a study for advanced bowel cancer where other treatments haven't worked.
It compares two medicines together (Regorafenib + Irinotecan) against one medicine (Regorafenib).
Patients are randomly assigned to one of the two treatment groups.
The aim is to find a more effective treatment option.
Your general health and specific genetic markers will be checked.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have bowel cancer that has spread to other parts of your body. Your cancer must also have gotten worse even after you've had various standard treatments. These typically include different types of chemotherapy and targeted therapies. Crucially, your cancer would also need to have a specific genetic marker called an "A/A cyclin D1 genotype."

You would also need to be reasonably fit and well for someone with advanced cancer, meaning you can carry out most of your daily activities without much help. Your doctors would check your general health, including your blood tests for your liver, kidneys, and blood cell counts, to make sure it's safe for you to take part.

It's important to discuss all your previous treatments and your current health with your doctor to see if this study could be right for you. If you are a woman who could become pregnant, you would also need to agree to use effective contraception during 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 at least 18 years old?
Do you have bowel cancer that has spread to other parts of your body?
Has your cancer progressed despite receiving several standard treatments?
Are you generally fit and able to do most of your daily activities?
Are you willing to have blood tests to check your specific cancer genotype?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the combination of Regorafenib and Irinotecan, or Regorafenib on its own. This is like flipping a coin, so neither you nor your doctor can choose which treatment you get. You will have regular hospital visits for blood tests, physical examinations, and scans to see how you are responding to the treatment.

The Regorafenib is a tablet you take by mouth, and the Irinotecan is given as an infusion (through a drip). The exact number of visits and the total duration would depend on how well you respond to the treatment and how long you are able to stay on it. You would also have follow-up appointments after you stop the treatment.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. Potential benefits include receiving a new experimental treatment that might be more effective than other options available, as well as close monitoring of your health. Potential risks might include side effects from the drugs, which can vary from mild to severe, or the treatment not working for your cancer. You will be told about all known side effects. It's very important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Centre Antoine Lacassagne
Verified postcode
Nice, France
Centre François Baclesse
Verified postcode
Caen, France
Hôpital Pontchaillou
Verified postcode
Rennes, France
Hôpital Robert Debré
Verified postcode
Reims, France
Institut Godinot
Verified postcode
Reims, France
Hôpital Saint-Jean
Verified postcode
Perpignan, France
Centre Léon Bérard
Verified postcode
Lyon, France
Hôpital privé Jean Mermoz
Verified postcode
Lyon, France
Institut Gustave Roussy
Verified postcode
Villejuif, France
CRLC Val d'Aurelle-Paul Lamarque
Verified postcode
Montpellier, France
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France

Common questions

What is advanced bowel cancer?

Advanced bowel cancer, also known as metastatic colorectal cancer, means the cancer has spread from your bowel to other parts of your body.

What are Regorafenib and Irinotecan?

These are both medicines used to treat cancer. Regorafenib is a tablet, and Irinotecan is usually given through a drip.

Why is this study important?

This study is important because it's looking for new treatment options for people with advanced bowel cancer when other standard treatments have stopped working.

Will I definitely get the new combination treatment?

No, you will be randomly assigned to either receive the combination treatment or Regorafenib on its own, like drawing lots.

What does 'performance status' mean?

'Performance status' is a way doctors measure how well you can do daily activities. A good performance status means you're generally well enough to participate in the study.