AuthorisedPhase II and Phase III (Integrated)Interventional

The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI

Advanced liver cancer can be treated with several medicines, including immunotherapy and targeted drugs. However, doctors do not yet know the best order in which to give these treatments to get the best results. This clinical trial studies different treatment paths to see which sequence helps patients live longer while keeping a good quality of life. Participants will receive standard cancer medicines under close medical care. The research team will track how well the tumours respond, monitor any side effects, and look at everyday well-being. The study also pays special attention to older adults to see how treatments affect daily living and independence. Taking part helps researchers improve future NHS guidelines for liver cancer care. The study is open to adults aged 18 and over who have advanced liver cancer and are preparing for systemic treatment.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Azienda Sanitaria Locale Napoli 1 Centro

Enrolment target

1,700

Start

14 Aug 2026

Advanced hepatocellular carcinoma

What is this study about?

Primary liver cancer, known as hepatocellular carcinoma, is often diagnosed when it is already advanced. In recent years, several new treatments have become available. These include targeted drugs, which block cancer growth signals, and immunotherapies, which help your body's own immune system fight the cancer.

While having more treatment options is positive, it creates a new challenge: doctors do not know which drug should come first, second, or third. Giving one medicine before another might make a significant difference to how long a person lives and how well they feel. This study follows patients through their treatment journey to find the most effective sequence of care.

The study looks at more than just survival. It also measures overall quality of life, daily energy levels, and common side effects. For older adults, the team will use simple surveys to check how well patients manage daily tasks at home. The ultimate goal is to give doctors clear evidence so every patient receives the best possible sequence of treatments.

Key takeaways

Tests the best sequence of modern medicines for advanced liver cancer.
Aims to help patients live longer while protecting quality of life.
All participants receive active, approved cancer drugs (no placebos).
Open to adults aged 18 and older in suitable general health.
Includes regular monitoring, scans, and simple well-being surveys.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with advanced hepatocellular carcinoma (the most common form of primary liver cancer). Both men and women can join.

To take part, you should be at a stage where you and your doctor are discussing systemic therapy. This means treatments that travel throughout the whole body, such as tablets or drips, rather than surgery or local treatments to the liver alone.

Your general health and liver function will need to meet safety standards. Your hospital care team will check your blood tests, heart health, and medical history to ensure that taking these medicines is 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.

I am aged 18 or older.
I have been diagnosed with advanced hepatocellular carcinoma (liver cancer).
I am planning to start or change systemic cancer treatment (pills or drips).
I am well enough to attend regular hospital appointments and scans.
My liver and kidneys are working well enough for cancer medicines.

Answer every question to see your result.

What does participation involve?

If you take part, you will follow a carefully planned sequence of cancer medicines chosen by your doctor and the study team. Some of these medicines are tablets taken at home, while others are given through a drip into a vein at the hospital clinic. You will have regular hospital visits to check your blood, monitor your blood pressure, and talk about any side effects. Every few months, you will have imaging scans, such as a CT or MRI scan, to see how the cancer is responding. You will also be asked to complete short questionnaires about your mood, energy levels, and how easily you manage everyday tasks. You will remain in the study for as long as the treatments are helping you and you wish to continue.

Potential risks and benefits

Taking part may give you access to a structured treatment plan with very close monitoring from liver cancer specialists. However, there is no guarantee that a specific sequence of medicines will work better than standard care. All cancer drugs have potential side effects, which may include tiredness, high blood pressure, loose stools, skin rashes, or changes in liver function. Your care team will watch you closely and provide treatments to relieve side effects. Joining the study is completely voluntary, and you can leave at any time without it affecting your standard NHS 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

Will I receive a dummy drug (placebo)?

No. Everyone in this study receives real, active cancer medicines. The study is comparing different sequences of proven treatments.

How are the medicines taken?

It depends on which treatment step you are on. Some medicines are daily tablets you swallow at home, while others are given via a drip at the hospital every few weeks.

Do I have to pay for the treatments?

No. In the UK, clinical trial medicines and study-related tests are provided free of charge through the hospital.

What happens if a medicine stops working?

Because this study looks at treatment journeys, your medical team will assess your condition and guide you toward the next planned treatment option in the sequence.

Can I leave the study if I find it too difficult?

Yes. You can leave the study at any point. You do not have to give a reason, and your regular doctor will continue to provide your standard NHS care.