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A liver cancer clinical trial - HE2

A study combining two treatments for liver cancer
Disease Site
Gastro-Intestinal Clinical Trials
Trial Code
HE.2 ǀ NCT06880523
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the effects on you and your liver cancer of adding a drug that is used on its own to treat this disease to a two-drug combination also used to treat liver cancer, compared to the two-drug combination alone.

Why is this study important?

An earlier clinical trial showed that the single drug treatment for liver cancer used in this study helped stabilize or shrink participants’ liver cancer and extend the time before their cancer got worse. A different clinical trial showed that the two-drug combination used in this study helped extend how long participants with liver cancer lived after starting the treatment. Researchers want to know if the combination of all three drugs in this study can offer better results than the current standard treatment.

Who can participate in this study?

This trial is for people:

  • with confirmed liver cancer
  • who have not had any other drug treatment for their liver cancer
  • with acceptable liver function
  • who can attend the required follow up visits

This trial is not for people:

  • who are HIV positive or have an active tuberculosis infection
  • who have an autoimmune or inflammatory disorder (some exceptions)
  • who have had another type of cancer within the last 5 years (some exceptions)
  • with active peptic ulcer disease (sores in the stomach or top of the colon), gastritis (inflammation of the stomach lining), or who have a condition that causes or increases your risk of bleeding more than usual
  • who have had major surgery in the past month
What are the risks?
  • If you choose to take part in this study, there is a risk that the combination of the three drugs may not be as good as the two-drug combination alone. There is also a risk that you could have more or different side effects from the additional drug. Some of the most common side effects that the study doctors know about are:
    • tiredness
    • high blood pressure
    • nausea and vomiting
    • diarrhea
    • decreased appetite which may lead to weight loss
  • You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either the single drug treatment plus the two-drug combination treatment, or only the two-drug combination treatment. In this study, you will also be asked to complete a few questionnaires at different times, to understand your Quality of Life.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The HE.2 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT06880523.

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.