Recruiting

Study on UCPVax, Atezolizumab, and Bevacizumab for Patients with Unresectable Liver Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of liver cancer known as unresectable hepatocellular carcinoma. This means the cancer cannot be removed with surgery. The study is testing a new treatment approach that combines a cancer vaccine called UCPVax with two other medications, atezolizumab and bevacizumab. The vaccine is designed to help the immune system fight cancer by targeting a specific protein, while atezolizumab and bevacizumab are drugs that help the immune system attack cancer cells and block the growth of blood vessels that feed tumors, respectively.

The purpose of the study is to see how effective this combination of treatments is for patients with this type of liver cancer. Participants in the study will receive these treatments and will be monitored over a period of time to see how their cancer responds. The study will look at how many patients experience a reduction in their cancer size or a halt in its growth after six months of treatment. Additionally, the study will observe the overall health and quality of life of the participants during the treatment period.

Throughout the study, participants will receive the treatments through injections and infusions. The study will also involve regular check-ups and tests to monitor the participants' health and the effects of the treatment. The goal is to gather information that could lead to new ways of treating liver cancer that cannot be removed with surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the criteria for participation are met.
Step 2
Treatment initiation
The treatment phase begins with the administration of the study medications. The first medication, UCPVax, is given as a subcutaneous injection. The dosage is 1 mg in 2 ml of emulsion for injection.
The second medication, MVASI (bevacizumab), is administered intravenously. It is a 25 mg/mL concentrate for solution for infusion.
The third medication, Tecentriq (atezolizumab), is also administered intravenously. It is a 1,200 mg concentrate for solution for infusion.
Step 3
Treatment schedule
The medications are administered according to a specific schedule. The frequency and duration of administration are determined by the study protocol and will be explained by the healthcare team.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical examinations, blood tests, and imaging studies as needed.
The objective response rate is evaluated at 6 months using specific criteria to determine the effectiveness of the treatment.
Step 5
Quality of life assessments
Every 8 weeks, assessments are conducted to evaluate health-related quality of life. This involves completing questionnaires designed to measure various aspects of well-being.
Step 6
End of treatment
At the end of the treatment period, a final evaluation is conducted to assess overall health and the outcomes of the study treatment.
Participants may be asked to continue follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

13 criteria

Must have signed an informed consent form, which means you agree to participate in the study after understanding its details.
Must be at least 18 years old.
Must have a measurable disease, which means the cancer can be measured using specific guidelines.
If you have had previous treatments like chemoembolization, radioembolization, or radiotherapy, you should have recovered from any side effects to a mild level, except for hair loss.
Must have a performance status of less than 2, meaning you are able to carry out daily activities with some limitations.
Must have a Child-Pugh Class A status, which is a way to assess liver function.
Females must use highly effective birth control and have a negative pregnancy test if they can have children, or show they cannot have children.
Must have documented hepatitis status, confirmed by tests for hepatitis B and C. If you have active hepatitis B, your viral load should be low, and you should be on treatment. If you have hepatitis C, you can participate whether the infection is resolved or ongoing.
Must have had an esophagogastroduodenoscopy, which is a procedure to check the upper digestive system, and treatment of any varices, which are enlarged veins, before starting the study.
Must be able to follow the study protocol, as judged by the study doctor.
Must have a confirmed diagnosis of hepatocellular carcinoma, which is a type of liver cancer.
Must have locally advanced, metastatic, or unresectable disease, meaning the cancer has spread or cannot be removed by surgery.
Must not have received previous systemic anti-cancer treatment, which means treatments that affect the entire body.

Who cannot join the trial?

12 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have had another cancer treatment recently.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medications.
Patients with a history of severe allergic reactions.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have had an organ transplant.
Patients with a history of drug or alcohol abuse.
Patients who are participating in another clinical trial.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centr Georges Francois Leclerc
Verified
Dijon, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

UCPVax
is a type of cancer vaccine that is designed to help the body's immune system fight cancer. It works by stimulating a specific part of the immune system, known as CD4 Th1 cells, to recognize and attack cancer cells. This vaccine is derived from a protein called telomerase, which is often found in cancer cells. By targeting this protein, UCPVax aims to boost the body's natural defenses against cancer.
Atezolizumab
is a medication that helps the immune system fight cancer. It is known as an immune checkpoint inhibitor. This means it works by blocking a specific protein that prevents the immune system from attacking cancer cells. By blocking this protein, atezolizumab allows the immune system to better recognize and destroy cancer cells.
Bevacizumab
is a medication that helps stop the growth of new blood vessels that tumors need to grow. It is known as an anti-angiogenic therapy. By preventing the formation of new blood vessels, bevacizumab can help slow down or stop the growth of tumors, making it harder for the cancer to spread.

What is already known about the treatment

UCPVax
UCPVax is a cancer vaccine administered through injection, designed to stimulate the immune system to target cancer cells. It is currently being studied in clinical trials for its effectiveness in treating unresectable hepatocellular carcinoma, a type of liver cancer. The vaccine works by inducing a specific type of immune response, known as CD4 Th1, which helps the body recognize and attack cancer cells. UCPVax is classified as an immunotherapy, a type of treatment that uses the body's own immune system to fight cancer.
Atezolizumab
Atezolizumab is an immunotherapy drug given by intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is approved for use in various cancers and is being studied for its potential in treating unresectable hepatocellular carcinoma. Atezolizumab works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. By inhibiting this protein, atezolizumab helps the immune system recognize and destroy cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors.
Bevacizumab
Bevacizumab is a medication administered through intravenous infusion, used to treat various types of cancer by inhibiting the growth of blood vessels that supply tumors. It is being evaluated in combination with other treatments for unresectable hepatocellular carcinoma. Bevacizumab works by targeting a protein called VEGF, which is responsible for the formation of new blood vessels. By blocking VEGF, bevacizumab helps to starve the tumor of nutrients and oxygen, slowing its growth. It is classified as an angiogenesis inhibitor.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease typically progresses from a localized tumor to more advanced stages, where it may become unresectable or spread to other parts of the body. As the cancer grows, it can cause symptoms like abdominal pain, weight loss, and jaundice. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. Over time, the cancer may metastasize, affecting other organs and systems.