AuthorisedTherapeutic exploratory (Phase II)Interventional

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study, called a Phase II trial, is looking at a type of liver cancer called intrahepatic cholangiocarcinoma that can't be treated with surgery. It aims to find out if adding a special treatment directly to the liver (called HAI FUDR/Dexamethasone) alongside regular chemotherapy (GemOx) is more effective than just having the regular chemotherapy alone. Researchers want to see if the combined treatment can stop the cancer from growing for longer. They will also compare how long people live, how much the tumours shrink, when the cancer might come back, and any side effects from each treatment plan.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrolment target

Start

08 Nov 2024

Unresectable intrahepatic cholangiocarcinoma

What is this study about?

This study is for individuals who have been diagnosed with a specific type of cancer called intrahepatic cholangiocarcinoma, which starts in the bile ducts inside the liver. Importantly, this study is for those whose cancer cannot be removed through surgery. The main goal is to see if a newer treatment approach is better at controlling the cancer than the standard treatment.

Currently, a common treatment for this type of cancer is chemotherapy with drugs called GemOx. This study wants to know if adding a special kind of treatment directly to the liver, using drugs called HAI FUDR/Dexamethasone, improves the results. The idea behind giving drugs directly to the liver is to deliver a higher dose to the cancer while potentially reducing side effects elsewhere in the body. Researchers will compare how long people's cancer stays stable without growing, as well as how long people live overall.

They will also look at other important things, like whether the tumours shrink, when the cancer might come back, and what side effects people experience with each treatment. Understanding the side effects is crucial for ensuring the treatment is tolerable. The study also aims to understand the unique genetic makeup of these cancers to see if specific characteristics affect how well treatments work.

Key takeaways

This study is for advanced liver cancer that cannot be removed by surgery.
It compares standard chemotherapy to a combination of chemotherapy and a targeted liver treatment.
The main aim is to see if the combination treatment stops cancer growth for longer.
Researchers will also look at overall survival, tumour shrinkage, and side effects.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

Importantly, your doctor must confirm that you have intrahepatic cholangiocarcinoma that cannot be removed surgically. There will be other specific medical criteria that your doctor will check to make sure the study treatments are safe and appropriate for you.

Things like your overall health, other medical conditions you might have, and previous treatments will be carefully reviewed by the study doctors to determine if you can join.

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 intrahepatic cholangiocarcinoma (a type of bile duct cancer in the liver)?
Has your doctor confirmed that your cancer cannot be removed by surgery?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to one of two treatment groups: either standard chemotherapy (GemOx) or the combined treatment (GemOx plus the special liver treatment). Your doctor will explain how these treatments are given, including details about infusions and how often you'll receive them.

You would have regular visits to the hospital for treatment, check-ups, and tests like scans and blood work to monitor your health and how the treatment is affecting the cancer. The study will also involve follow-up appointments after your treatment period potentially ends, to continue monitoring your health and the cancer.

The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, which your care team will discuss with you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new or different treatment approach that could be more effective than standard care for your cancer. However, there's no guarantee that the treatment will work for you, and your cancer may not respond. As with all medical treatments, there are potential risks, including side effects from the chemotherapy and the special liver treatment. These side effects can vary from person to person and your healthcare team will discuss them in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What is 'unresectable' cancer?

Unresectable means the cancer cannot be completely removed by surgery, either because of where it's located or because it has spread too much.

What is a 'Phase II' study?

A Phase II study usually checks if a new treatment is effective and safe in a larger group of people after early safety tests. It's often comparing it to a standard treatment.

What does 'Progression-free survival' mean?

This is how long a person lives with the cancer without it getting worse or spreading to new areas.

What is 'systemic chemotherapy' compared to 'HAI FUDR/Dexamethasone'?

Systemic chemotherapy travels through your bloodstream to treat cancer throughout your body. HAI FUDR/Dexamethasone is a treatment given directly into the artery supplying the liver, aiming to target the liver cancer more directly.

Will I know which treatment I'm getting?

In some studies, you might be assigned to a treatment group randomly, meaning a computer decides, and sometimes neither you nor your doctor knows until treatment starts. Your study team can explain this specific detail to you.