Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II study evaluating Holmium-166 TARE followed by maIntenance Therapy in liver limited unresectable colorectal cancer patients after first-lIne chemotherapy and target agents: The HAITI study.

This study, called HAITI, is investigating a new treatment approach for people with bowel cancer that has spread only to the liver and cannot be removed by surgery. These patients have already had their first round of chemotherapy and other targeted drugs. The study is combining a special targeted radiation treatment to the liver, called Holmium-166 TARE, with ongoing maintenance chemotherapy and targeted drugs. Researchers want to see if this combination can stop the cancer from growing for a longer time compared to standard care. They will also look at side effects, how well the treatment shrinks the cancer, and how it affects people's quality of life. This is a Phase II study, meaning it's exploring how well and safely this new approach works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Gruppo Oncologico Del Nord Ovest

Enrolment target

Start

18 Dec 2023

Liver limited unresectable colorectal cancer

What is this study about?

This study is for people who have bowel (colorectal) cancer that has spread only to their liver, and where doctors can't remove the cancer through an operation. These patients have already started treatment and received their first round of chemotherapy and targeted drugs. The study, called HAITI, is looking at a new way to treat this type of cancer. It combines a special kind of internal radiation treatment directly to the liver with ongoing cancer medications.

The main aim of the study is to see if this new combined treatment can stop the cancer from growing or spreading for a longer period. Doctors will be measuring how many patients have their cancer kept under control for 8 or 9 months after starting this treatment. They also want to understand the side effects, how much the cancer shrinks, and how the treatment impacts a person's general well-being and daily life.

This is a Phase II study, which means it's an important step in testing new treatments. It helps doctors learn more about the safety and effectiveness of this new approach before it can potentially become a standard treatment option. By taking part, patients help us learn crucial information that could benefit future patients with the same condition.

Key takeaways

This study is for bowel cancer that has spread only to the liver and cannot be removed by surgery.
It combines special liver radiation with ongoing cancer medicines.
The main goal is to see if cancer growth can be stopped for longer.
It's a Phase II study, exploring effectiveness and safety.
Participants must be adults who have already started chemotherapy.

Who may be eligible?

To be part of this study, you must be an adult, aged 18 years or older, with no upper age limit. Both men and women can take part in this research.

You would be considered for this study if you have bowel cancer that has spread to your liver, but only your liver. Importantly, the doctors must have decided that the cancer in your liver cannot be removed by surgery. You would also need to have already received your first course of chemotherapy and other targeted medicines for your cancer.

There might be other health requirements or test results needed to ensure the treatment is safe and suitable for you. Your medical team will go through all these details carefully with you to determine if this study is a good fit for your situation.

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 bowel cancer that has spread only to your liver?
Has your doctor said the cancer in your liver cannot be removed by surgery?
Have you already had your first course of chemotherapy and targeted cancer medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a series of initial checks and tests to make sure the treatment is right for you. This would involve scans and blood tests. The main treatment involves a special radiation therapy to your liver, called Holmium-166 TARE, which is given once. After this, you would continue to receive maintenance cancer medicines like Capecitabine, Bevacizumab, Cetuximab, Panitumumab, Fluorouracil, or Calcium Levofolinate, depending on which group you are in and what your doctors decide is best.

You would have regular visits to the hospital for blood tests, scans, and check-ups to monitor how you are doing, how the treatment is working, and to manage any side effects. The exact number of visits and the full duration of your participation would depend on how your treatment is going and how long you are responding to it. You would be closely monitored throughout the study.

Potential risks and benefits

Potential benefits of joining this study include the possibility that this new combined treatment could keep your cancer from growing for longer or shrink it more effectively than current standard treatments. You would also have very close medical monitoring. However, as with all medical treatments, there are potential risks and side effects from the radiation and the cancer medicines. These can vary from mild to more serious and your doctors will explain all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is 'liver limited unresectable colorectal cancer'?

This means you have bowel (colorectal) cancer that has spread, but only to your liver, and doctors can't remove it with an operation.

What is Holmium-166 TARE?

It's a special type of targeted radiation treatment that’s delivered directly to the liver to fight the cancer cells there.

Will I still receive my regular cancer medicines?

Yes, after the special radiation treatment, you will continue with some of your regular cancer medicines as part of this study to help control the cancer.

What does 'Phase II' mean for a study?

Phase II means doctors are exploring how well a new treatment works and its safety, after initial safety tests have been done. It's an important step before wider use.

How long will I be in the study?

The length of time you'll be in the study varies. It depends on how you respond to the treatment and how long the treatment is effective for you. Your doctor will provide more specific details.