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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Hopital Prive Sainte Marie Chalon	Chalon Sur Saone	France
Hopital Beaujon	Clichy	France
Hopital Nord Franche-Comte	Belfort	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hospital Paul Brousse	Villejuif	France
Blockjcb Usrvbvgwlf Hppempwv Cqyelw	Besançon	France
Ctquhv Lxff Bdaszc	Lyon	France
Ixmhtifw Mkzlnpechq Madocccebj	Paris	France
Hgcttud Hzxpw Maxovx &xgshti 1 rjv Ghhyvub Euiqem	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2022

Trial locations

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.

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.

Trial ID:

2022-500643-20-00

Protocol code:

2022/680

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?