Active not recruitingPHASE1INTERVENTIONAL

Study Investigating the Association of NP137 With Atezolizumab-Bevacizumab Combination in First Line in Unresectable HCC

This research study is investigating a new treatment for a type of advanced liver cancer called hepatocellular carcinoma, specifically when surgery isn't an option. The study is combining a new drug called NP137 with a standard treatment that uses two existing drugs, Atezolizumab and Bevacizumab. The main goal is to check how safe this new combination is for patients. Researchers also want to see if adding NP137 might lead to better tumour response and help patients live longer, while keeping side effects manageable. This initial phase of the study is called a 'Phase 1' trial, which means it's one of the first times this combination is being tested in people to find the right dose and understand its safety.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University Hospital, Grenoble

Enrolment target

Start

15 Mar 2023

Estimated completion

19 Mar 2029

Hepatocellular Carcinoma

What is this study about?

This study is about a type of cancer that starts in the liver, called hepatocellular carcinoma, which has become advanced and can't be treated with surgery. We're looking into a new treatment approach that combines a new study drug, called NP137, with a standard treatment made up of two drugs, Atezolizumab and Bevacizumab. These standard drugs are already used together for this condition, but we want to see if adding NP137 could make the treatment even better.

The main aim of this first phase of the study is to find out if this new combination is safe for patients. We also hope that by adding NP137, we might see the cancer respond better to treatment, potentially shrinking tumours more effectively, and that patients might live longer. It's really important that any new treatment is not only effective but also safe and well-tolerated.

This is a 'Phase 1' study, which means it's one of the first steps in testing a new treatment in people. We're starting with a small group of patients to carefully check for any side effects and to work out the best dose of NP137 to use. Once we've done that, more patients will join the study to continue looking at the safety and initial effects of this combined treatment.

Key takeaways

This study is for advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed.
It combines a new drug (NP137) with two existing treatments (Atezolizumab and Bevacizumab).
The main aim is to check the safety of this new drug combination.
Researchers hope it could lead to better cancer response and help patients live longer.
It's a 'Phase 1' study, which focuses on safety and finding the right dose.
Participation includes regular check-ups, scans, and a liver biopsy.

Who may be eligible?

This study is looking for adults aged 18 or over who have a specific type of advanced liver cancer (hepatocellular carcinoma) that doctors can't remove with surgery. You will only be considered if you haven't had other widespread treatments for your advanced liver cancer before.

There are also some important health checks you'd need to pass. For example, your liver, kidney, and blood tests would need to show that these organs are working well enough to take part. You also need to be generally well and able to carry out your daily activities without too much difficulty.

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 a diagnosis of advanced liver cancer (hepatocellular carcinoma) that surgeons can't remove?
Have you NOT received any previous widespread drug treatments for your advanced liver cancer?
Are your liver, kidney, and blood tests generally within healthy limits?
Are you generally able to manage your daily activities without too much difficulty?
Are you willing to have a liver biopsy during the study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the combination of the new drug NP137, along with Atezolizumab and Bevacizumab. Initially, a small group of 3 to 12 patients will help us work out the best dose of NP137. After that, another 40 patients will receive the treatment at this confirmed safe dose. You'll have regular hospital visits, blood tests, and scans to monitor your health and how the treatment is affecting the cancer. You will also need to have a liver biopsy (a small sample of liver tissue taken) sometime between your fourth and fifth treatment cycles. The total duration of your participation will depend on how you respond to the treatment and your overall health, but you would be regularly monitored.

Potential risks and benefits

Taking part in this study means you could be among the first to receive a new combination treatment that might offer a new way to fight your liver cancer, with the hope of better outcomes. However, as with all new treatments, there are potential risks, including side effects from the study drugs. We don't yet know all the side effects of this specific combination, but they will be carefully monitored. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

CHU de GRENOBLE ALPES
Verified postcode
Grenoble, France
CHU Angers
Verified postcode
Angers, France
Hôpital Haut Lêveque
Verified postcode
Bordeaux, France
12 Hôpital St Joseph
Verified postcode
Marseille, France
CHU Nantes
Verified postcode
Nantes, France
AP-HP Beaujon
Verified postcode
Paris, France
AP-HP St Antoine
Verified postcode
Paris, France
CHU Reims
Verified postcode
Reims, France
CHU Toulouse
Verified postcode
Toulouse, France

Common questions

What is hepatocellular carcinoma?

It's the most common type of cancer that starts in the liver. This study is for advanced cases that can't be removed by surgery.

What is a 'Phase 1' study?

It's an early stage of clinical research where a new treatment is tried in people for the first time. The main goal is to check its safety and find the right dose.

Will I take NP137 alone?

No, if you join this study, you will receive NP137 combined with two other drugs, Atezolizumab and Bevacizumab, which are already used for this type of cancer.

Do I need to have a liver biopsy?

Yes, part of participating means you'll need to have a liver biopsy during the study (between your fourth and fifth treatment cycle).

What does 'unresectable' mean?

It means the cancer can't be removed by surgery because of its size, location, or if it has spread too much within the liver.