RecruitingPHASE2INTERVENTIONAL

- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases

This study is for people with advanced bowel cancer that has spread to other parts of the body (metastatic), but does not have active liver metastases. It's for a specific type of bowel cancer called MSS/pMMR. Researchers want to compare a new treatment combination — Fruquintinib taken as a pill and Tislelizumab given intravenously — against a standard treatment combination of Trifluridine/tipiracil (pills) and Bevacizumab (intravenous). The goal is to see which combination is more effective. Participants will be randomly assigned to one of these two groups. This is a Phase 2 study for people who have already had at least one other treatment for their cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

140

Start

27 Oct 2025

Estimated completion

31 Dec 2029

Metastatic Colorectal Cancer

What is this study about?

This study is looking into new ways to treat advanced bowel cancer (also called colorectal cancer) that has spread to other parts of the body. This is specifically for a type of advanced bowel cancer that doesn't have active liver metastases at the time of the study and is categorised as MSS/pMMR. You may have heard of treatments like chemotherapy; this study is exploring different kinds of medicines.

The main aim is to see if a new combination of two drugs, Fruquintinib and Tislelizumab, works better than a standard treatment often used for this type of cancer. Fruquintinib is a pill you take, and Tislelizumab is given through a drip (like an IV). The standard treatment being compared is also a combination: Trifluridine/tipiracil, which is taken as pills, and Bevacizumab, which is given through a drip.

By comparing these two treatment approaches, doctors hope to find a more effective way to help people with this specific kind of advanced bowel cancer. This type of research, called a clinical trial, helps us understand which treatments are best and leads to better care in the future. It's important to remember that this study is still in an earlier phase (Phase 2), meaning these treatments are still being carefully investigated.

Key takeaways

This study is for advanced bowel cancer that has spread but NOT to the liver at the time of joining.
It's comparing a new drug combination with a standard treatment.
You'll be randomly assigned to one of two treatment groups.
Treatment may last up to 15 months, with follow-up for up to 18 months.
Regular hospital visits, blood tests, and scans will monitor your health.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced bowel cancer that has spread, but without active liver tumours at the moment you join. Your bowel cancer also needs to be of a specific type called MSS/pMMR. Doctors will need to know about certain gene changes (like RAS and BRAF) in your cancer cells.

You would have already received at least one course of treatment for your advanced bowel cancer, or not been able to take those treatments. You also need to be well enough to take part, meaning you can mostly look after yourself. The medical team will check your general health, including blood tests for your liver, kidneys, and blood cells.

If you've had liver tumours treated in the past, you might still be able to join, as long as they were fully treated (for example, with surgery or certain types of burning) at least three months ago and haven't shown any signs of growing back since then. If you think you might fit these criteria, your doctor can help you understand all the details.

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 over?
Do you have advanced bowel cancer that has spread, but currently without active growth in your liver?
Have you already received at least one other treatment for your advanced bowel cancer?
Are you generally well enough to go about your daily life with minor effort?
Has your doctor confirmed your cancer type is MSS/pMMR?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly put into one of two groups. This is like flipping a coin for fairness. In one group, you'll take Fruquintinib pills once a day for 21 days out of a 28-day cycle, and receive Tislelizumab through a drip every six weeks. In the other group, you'll take Trifluridine/tipiracil pills twice a day for a total of 10 days within a 28-day cycle, and receive Bevacizumab through a drip every two weeks.

You will continue your treatment until your cancer starts to get worse, you experience side effects that are too difficult to manage, you decide you no longer want to participate, or for a maximum of 15 months. During the study, you'll have regular hospital visits for blood tests, scans, and check-ups to monitor your health and how the treatment is working. After you finish treatment, you will be followed up by the study team for up to 18 months to see how you are doing.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. The potential benefit of this study is that one of the new treatment combinations might work better for your cancer than available options. However, there's no guarantee it will work for everyone, or that it will be better than existing treatments. Like all medicines, both combinations can cause side effects. The study team will explain these in detail so you can make an informed decision. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (23)

Ordensklinikum Linz GmbH
Verified postcode
Linz, Austria· Not yet recruiting
SCRI CCCIT Ges.m.b.H.
Verified postcode
Salzburg, Austria· Recruiting
Noe LGA Gesundheit Thermenregion GmbH
Verified postcode
Wiener Neustadt, Austria· Not yet recruiting
Klinikum St. Marien Amberg
Verified postcode
Amberg, Germany· Recruiting
HELIOS Klinikum Bad Saarow
Verified postcode
Bad Saarow, Germany· Recruiting
Charite Universitaetsmedizin Berlin KöR
Verified postcode
Berlin, Germany· Recruiting
HELIOS Emil von Behring Berlin
Verified postcode
Berlin, Germany· Recruiting
Katholisches Klinikum Bochum gGmbH
Verified postcode
Bochum, Germany· Not yet recruiting
Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale
Verified postcode
Düsseldorf, Germany· Not yet recruiting
KEM | Klinik für Internistische Onkologie gGmbH
Verified postcode
Essen, Germany· Recruiting
Universitätsklinikum Essen
Verified postcode
Essen, Germany· Not yet recruiting
Goethe University Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting

Common questions

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started (in this case, the bowel) to other parts of your body through your bloodstream or lymphatic system.

What is MSS/pMMR colorectal cancer?

MSS/pMMR refers to specific features of your cancer cells that doctors look for in lab tests. It helps them understand how your cancer might respond to certain treatments.

Why can't I have active liver metastases?

This study is specifically designed for people whose bowel cancer hasn't actively spread to the liver when they join. This helps the researchers focus on how the treatments work in this particular situation.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment combination you are receiving.

Can I still participate if I've had liver tumours in the past?

Yes, if your liver tumours were treated at least three months ago with certain methods (like surgery) and show no signs of growing back, you might still be able to join.

How to find out more

Alexander Stein, Prof. Dr.

stein@hope-hamburg.de +494036035220 Official trial record

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