Not recruitingRare disease

Study of Durvalumab, Tremelimumab, and Bevacizumab for Patients with Non-Resectable Liver Cancer

Verified siteRegistered drugNo placebo

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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 called non-resectable hepatocellular carcinoma (HCC). The study will explore the effects of a combination of three treatments: Durvalumab, Tremelimumab, and Bevacizumab. These treatments are given as solutions through an infusion, which means they are delivered directly into the bloodstream through a vein. The purpose of the study is to assess how effective these treatments are when used together, either in sequence or all at once, compared to past treatments for this type of cancer.

Participants in the study will receive the treatments over a period of up to 24 months. The study will monitor various outcomes, such as how well the cancer responds to the treatment, how long patients live, and how long they live without the cancer getting worse. The study will also look at the quality of life of the participants and any side effects they may experience. The goal is to gather information that could help improve treatment options for people with this type of liver cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient will provide informed consent, confirming understanding and agreement to comply with the study requirements.
Eligibility is confirmed based on specific criteria, including age, weight, and medical history related to hepatocellular carcinoma (HCC).
Step 2
Initial Assessment
A comprehensive medical evaluation is conducted to establish baseline health status. This includes imaging tests like CT or MRI to measure any tumors.
Blood tests are performed to assess liver function and other organ health.
Step 3
Treatment Phase
The patient receives a combination of medications: durvalumab, tremelimumab, and bevacizumab. These are administered as solutions for infusion.
The treatment is given through intravenous infusion, following a specific schedule determined by the study protocol.
Step 4
Monitoring and Follow-up
Regular follow-up visits are scheduled to monitor the patient's response to treatment and overall health.
Blood tests and imaging studies are repeated periodically to assess the effectiveness of the treatment and to detect any side effects.
Step 5
Completion and Evaluation
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.
The patient's health and any changes in the condition of the liver or tumors are documented.

Who can join the trial?

16 criteria

Must be able to give signed informed consent, which means agreeing to follow the study rules and procedures.
Must be at least 18 years old.
Must weigh more than 30 kg (about 66 pounds).
Must have a confirmed diagnosis of **hepatocellular carcinoma (HCC)**, a type of liver cancer, based on tissue samples.
Must not have received any previous systemic therapy, which means treatment that affects the whole body, for HCC.
Must not be eligible for locoregional therapy, which is treatment directed at a specific area, for unresectable HCC. If locoregional therapy was done, it must have been completed at least 28 days before the study starts.
Must have **Barcelona Clinic Liver Cancer (BCLC) stage B** or stage C, which are classifications of liver cancer stages.
Must have a **Child-Pugh Score class A**, which is a measure of liver function.
Must have an **ECOG performance status** of 0 or 1, which indicates the level of daily activity and ability to care for oneself.
If infected with **HBV** (Hepatitis B virus), must be on antiviral therapy to control the virus before joining the study and continue it during the study and for 6 months after the last dose of study medication.
If infected with **HCV** (Hepatitis C virus), must have a confirmed diagnosis based on specific tests.
Must have at least one measurable lesion, which is a tumor that can be measured accurately using imaging tests like CT or MRI.
Must have adequate organ and bone marrow function, which means the body is working well enough to handle the study treatment. This includes specific levels of blood cells, liver enzymes, and kidney function.
For women, must show evidence of being post-menopausal or have a negative pregnancy test if pre-menopausal.
Must be willing and able to follow the study protocol, including attending all visits and undergoing all tests and treatments.
Must have a life expectancy of at least 12 weeks.

Who cannot join the trial?

3 criteria

Patients with other types of cancer that are not **non-resectable hepatocellular carcinoma (HCC)**. This means the study is only for those with a specific type of liver cancer that cannot be removed by surgery.
Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
Patients who are part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves, are not included.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Pisana
Verified
Pisa, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Durvalumab
is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being tested for its effectiveness in treating non-resectable hepatocellular carcinoma, a type of liver cancer.
Tremelimumab
is another medication that helps the immune system fight cancer. It is often used in combination with other drugs to enhance the body's immune response against cancer cells. This trial is exploring its use alongside other treatments for liver cancer.
Bevacizumab
is a medication that inhibits the growth of blood vessels that supply nutrients to tumors. By blocking these blood vessels, it can help slow or stop the growth of cancer. In this trial, it is being used to see if it can improve outcomes for patients with liver cancer when used with other therapies.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating non-resectable hepatocellular carcinoma (HCC). The medication works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. It is classified as an immune checkpoint inhibitor.
Tremelimumab
Tremelimumab is given through intravenous infusion. It is under investigation in clinical trials for its potential to treat non-resectable hepatocellular carcinoma (HCC). This medication targets and blocks CTLA-4, a protein that downregulates the immune response, thereby enhancing the body's ability to fight cancer. It belongs to the class of immune checkpoint inhibitors.
Bevacizumab
Bevacizumab is administered via intravenous infusion. It is being evaluated in clinical trials for its role in treating non-resectable hepatocellular carcinoma (HCC). The drug works by inhibiting vascular endothelial growth factor (VEGF), which is involved in the formation of new blood vessels that tumors need to grow. Bevacizumab is classified as an angiogenesis inhibitor.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma (HCC) is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It is often associated with chronic liver diseases such as hepatitis and cirrhosis. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the cancer advances, it may cause symptoms like abdominal pain, weight loss, and jaundice. HCC is considered non-resectable when it cannot be surgically removed due to its size, location, or spread. The progression of the disease can lead to liver dysfunction and other complications.