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RecruitingPHASE2INTERVENTIONAL

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease

This study is for people in the UK with bowel cancer that has spread to the liver and has not responded to previous treatments. It explores whether a special treatment, where chemotherapy (melphalan) is given directly to the liver, followed by standard cancer drugs, is safe and works better than standard cancer drugs alone. The study is particularly interested in bowel cancer where the liver is the main area affected by the spread of the disease. Participants will either receive the liver-targeted chemotherapy twice, followed by standard drugs, or just the standard cancer drugs. Everyone will have regular check-ups, scans, and blood tests to monitor their health and how their cancer is responding over time. The main goal is to find out if this new approach can help control the cancer in the liver more effectively.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Delcath Systems Inc.
Enrolment target
90
Start
05 Aug 2025
Estimated completion
01 Oct 2027

What is this study about?

This study is for people who have bowel (colorectal) cancer that has spread to the liver, and where this spread is the main concern. Your doctors may call this 'metastatic colorectal cancer with liver-dominant disease.' It means the cancer has moved from your bowel to your liver, and your liver is the primary place where the cancer is causing problems, even if there might be small amounts of cancer elsewhere.

The purpose of this research is to see if a special treatment, called 'high-dose melphalan given directly into the liver,' can help control the cancer in your liver. This treatment delivers strong chemotherapy specifically to the liver. The study wants to find out if this liver-focused treatment, when followed by standard cancer medications, is safe and works better than just receiving the standard cancer medications on their own. The standard cancer medications used in this study are 'trifluridine-tipiracil' and 'bevacizumab' which are already approved for use.

About 90 patients will take part across different medical centres. Two out of three patients will receive the liver treatment followed by the standard drugs, and one out of three will receive just the standard drugs. This allows doctors to compare the two approaches fairly. This is a 'Phase 2' study, which means it's one of the earlier stages of testing a new treatment combination in people, focusing on its safety and whether it shows promise in treating the disease.

Key takeaways

  • New study for bowel cancer that has spread mainly to the liver.
  • Compares liver-targeted chemotherapy with standard cancer drugs.
  • Around 90 patients will participate across different centres.
  • Regular check-ups and scans every two months are part of taking part.
  • You can leave the study at any time.
  • Aims to find safer, more effective treatments for this type of cancer.

Who may be eligible?

To join this study, you must have bowel cancer that has spread to your liver, and your liver must be the main area affected by the cancer. The cancer in your liver should be measurable on scans. If the cancer has spread outside the liver, it can only be to a very limited extent, like small spots in the lungs or nearby lymph nodes.

You should have already tried and not responded to, or couldn't tolerate, other common chemotherapy drugs for bowel cancer. You also need to be generally well enough to take part in a study like this, as determined by your healthcare team. This study is for people aged 18 and over.

There are some reasons you may not be able to join. For example, if you have a serious liver condition like advanced cirrhosis, or significant heart problems. Your medical team will carefully check all these points to see if this study is suitable and safe for you.

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.

  1. Do I have bowel cancer that has spread to my liver?
  2. Is my liver the main area affected by the cancer spread?
  3. Have I already tried standard chemotherapy for bowel cancer?
  4. Am I over 18 years old?
  5. Do I have serious liver or heart problems?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups. Two out of three people will receive up to two special treatments where the chemotherapy is given directly to the liver, followed by standard cancer medications. The other group will receive only the standard cancer medications. The standard medications will continue as long as they are working and you are tolerating them well.

Throughout the study, you will have regular clinic visits, usually every two weeks, for check-ups and blood tests. You will also have scans, such as CT or MRI, about every two months to see how the treatment is affecting your cancer. These tests help the doctors monitor your health and the progress of your treatment. The study will continue until your cancer progresses, you experience side effects that are too difficult to manage, or if you decide to stop participating.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment or a new combination of treatments that could help your condition. However, there's no guarantee the treatment will work for you, and it may not be better than existing treatments. All cancer treatments, including those in this study, have potential side effects and risks. The research team will explain these risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

  • City of Hope
    Verified postcode
    Duarte, United States· Recruiting
  • UCLA Hematology/Oncology-Santa Monica
    Verified postcode
    Santa Monica, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • The University of Kansas Clinical Research Center
    Verified postcode
    Fairway, United States· Recruiting
  • Ochsner Clinic Foundation
    Verified postcode
    New Orleans, United States· Recruiting
  • Huntsman Cancer Institute, University of Utah
    Verified postcode
    Salt Lake City, United States· Recruiting
  • Czech Republic - University Hospital
    Verified postcode
    Prague, Czechia· Recruiting
  • Medizinische Hochschule Hannover
    Verified postcode
    Hanover, Germany· Recruiting
  • Helios Park-Klinikum Leipzig
    Verified postcode
    Leipzig, Germany· Recruiting
  • Instiuto Europeo de Oncologia
    Verified postcode
    Milan, Italy· Recruiting
  • Leiden University Medical Center (LUMC)
    Verified postcode
    Leiden, Netherlands· Recruiting
  • Clinical Hospital Center "Bezanijska Kosa"
    Verified postcode
    Belgrade, Serbia· Recruiting

Common questions

What does 'liver-dominant disease' mean?

It means that while your bowel cancer has spread, most of the cancer and the main challenge for your health is located in your liver.

What is 'high-dose melphalan given directly into the liver'?

This is a treatment where a strong chemotherapy drug (melphalan) is delivered straight into your liver to target the cancer there more directly.

What are 'trifluridine-tipiracil' and 'bevacizumab'?

These are standard cancer medications that are already approved and commonly used to treat bowel cancer that has spread.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, meaning both you and your medical team will know which treatment you are receiving.

How long will I be in the study?

You will continue treatment until your cancer progresses, you experience difficult side effects, or you choose to stop.

How to find out more

Matthew Cooney, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the Safety and Efficacy of Treatment w/High Do…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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