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Study on Atezolizumab, Bevacizumab, and EXL01 for Patients with Liver Cancer Not Responding to First-Line Immunotherapy

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as hepatocellular carcinoma (HCC). The study aims to evaluate the effectiveness of a combination treatment involving two medications, atezolizumab and bevacizumab, along with a supplement made from a special type of bacteria. Atezolizumab and bevacizumab are given as infusions, which means they are administered directly into the bloodstream through a vein. The bacterial supplement, known by the code name EXL01, is taken orally in the form of a capsule.

The purpose of this study is to see how well this combination treatment works in patients whose HCC has progressed despite receiving initial immunotherapy. Participants in the study will receive the treatment over a period of up to 12 months. During this time, they will have regular check-ups to monitor their health and the response of their cancer to the treatment. The study will also look at how long patients live without their cancer getting worse and their overall survival time.

Throughout the study, any side effects experienced by participants will be closely monitored. The study will help researchers understand if adding the bacterial supplement to the existing treatment can improve outcomes for patients with HCC. This research is important for developing new ways to treat liver cancer and potentially improve the quality of life for those affected by this disease.

1 joining the study

Upon joining the study, the patient must have signed a written informed consent and meet the inclusion criteria, such as being 18 years or older and having a diagnosis of hepatocellular carcinoma (HCC).

2 initial assessment

An initial assessment is conducted to confirm the patient’s eligibility, including evaluations of liver function, overall health status, and disease progression.

3 treatment initiation

The treatment involves the administration of atezolizumab and bevacizumab through infusion. The specific dosages are 840 mg for atezolizumab and 25 mg/ml for bevacizumab. These medications are given as a solution for infusion.

4 bacterial supplementation

In addition to the infusion treatments, the patient receives EXL01 in capsule form, which is taken orally. This is part of the bacterial supplementation strategy.

5 monitoring and follow-up

The patient’s response to the treatment is monitored at various intervals, including weeks 6 and 12, and months 6 and 12. The objective is to evaluate the tumor response and overall survival.

Adverse events are tracked from the start of the treatment until 30 days after the last intake of EXL01.

6 completion of study

The study is estimated to conclude by January 15, 2026. The patient’s participation continues until the end of the study or until progression or other criteria are met.

Who Can Join the Study?

  • Can be either male or female.
  • Must sign a written document agreeing to participate, known as an Informed Consent.
  • Must be 18 years or older at the time of signing the informed consent.
  • Must have a condition called Hepatocellular Carcinoma (HCC), which is a type of liver cancer, diagnosed by specific medical tests.
  • The cancer must be at an advanced stage, spread to other parts of the body, or cannot be removed by surgery, as determined by a team of medical experts.
  • The disease must have worsened after treatment with a combination of two drugs, atezolizumab and bevacizumab.
  • Must have a liver function status called Child-Pugh A, which is a way to measure how well the liver is working, checked within 7 days before joining the study.
  • Must have an ECOG Performance status of 0 to 1, which is a scale used to assess how well a person can perform daily activities.
  • Must have adequate blood and kidney function, meaning:
    • Hemoglobin level greater than 8.5 grams per deciliter (g/dL).
    • Platelet count greater than 60 billion per liter (G/L).
    • Neutrophil count greater than 1.5 billion per liter (G/L).
    • Kidney function with a creatinine clearance greater than 50 milliliters per minute, measured by specific formulas.
  • The disease must be measurable by a standard called RECIST 1.1, which is a set of rules used to measure how cancer responds to treatment.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than hepatocellular carcinoma (a type of liver cancer).
  • Patients who have not shown progression after the first line of immunotherapy (a treatment that helps your immune system fight cancer).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to provide informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Hôpital Avicenne Bobigny France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
12.03.2025

Trial locations

Investigated drugs:

Atezolizumab 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 used to treat patients with liver cancer who have not responded to initial immunotherapy.

Bevacizumab is another cancer treatment medication. It works by blocking the growth of new blood vessels that tumors need to grow. In this trial, it is used alongside atezolizumab to enhance the treatment’s effectiveness in liver cancer patients.

Bacterial Supplementation involves using specific bacteria to potentially improve the body’s response to cancer treatment. In this trial, it is combined with atezolizumab and bevacizumab to see if it can help improve outcomes for patients with liver cancer.

Hepatocellular carcinoma – This 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 by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression can vary, with some tumors growing slowly while others may spread rapidly. The disease is often diagnosed at an advanced stage due to the lack of early symptoms.

Trial ID:
2023-508201-25-00
Protocol code:
2023-1-69-001
Trial Phase:
Therapeutic exploratory (Phase II)

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