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Study of Atezolizumab with Lenvatinib or Sorafenib vs Lenvatinib or Sorafenib alone in Unresectable Hepatocellular Carcinoma after Atezolizumab and Bevacizumab

Fast replyRegistered drugNo placebo
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What is this trial about?

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

In this research, adults with hepatocellular carcinoma that cannot be removed by surgery are being studied. The disease is a type of liver cancer that grows inside the liver and is not eligible for operation. The study examines the use of an intravenous medicine called atezolizumab, which is given through a drip into a vein, together with oral medicines lenvatinib or sorafenib, compared with the oral medicines alone. The purpose is to see whether the combination improves overall survival, meaning the length of time patients live after starting the study.

Participants are randomly assigned to receive either the combination therapy or a single oral drug, and treatment continues until disease progression or unacceptable side effects occur. Visits include regular health checks, blood tests, and imaging scans to monitor the tumor and overall health. The study follows patients for several months to record how long they live, how long the disease stays stable, and any side effects that arise.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After you join the study you will be randomly assigned to one of two treatment groups. one group receives a combination of atezolizumab plus either lenvatinib or sorafenib. the other group receives only lenvatinib or only sorafenib.

  2. Step 2

    Baseline assessments

    Before any medication is given you will undergo baseline tests. these may include blood tests, imaging scans, and measurements of vital signs to document the current status of your liver cancer.

  3. Step 3

    Start of medication

    Once randomization is complete you will begin the study medication(s).

    atezolizumab is supplied as a 1200 mg solution for infusion and is given by iv infusion (through a vein).

    lenvatinib is supplied as a 12 mg hard capsule taken by mouth.

    sorafenib is supplied as an 800 mg film‑coated tablet taken by mouth.

    The exact frequency and duration of each medication are defined by the study protocol and will be followed throughout the trial.

  4. Step 4

    Ongoing treatment

    You will continue to receive the assigned medication(s) according to the schedule set by the protocol. treatment continues until disease progression, unacceptable side effects, or the end of the study period.

  5. Step 5

    Monitoring visits

    Regular clinic visits are scheduled to monitor your health. during these visits blood samples, vital‑sign checks, and quality‑of‑life questionnaires may be collected. imaging studies may be performed to assess the status of the cancer.

  6. Step 6

    End of treatment

    If the cancer progresses or side effects become unacceptable, the study medication(s) will be stopped.

  7. Step 7

    Follow‑up

    After treatment ends you may continue to have follow‑up visits. these visits collect information about overall survival and any long‑term effects.

Who can join the trial?

7 criteria

  • You must have liver cancer called hepatocellular carcinoma (HCC) that is locally advanced, has spread (metastatic), or cannot be removed by surgery, and the diagnosis must be confirmed by a tissue test (histology or cytology) or by accepted clinical guidelines from the American Association for the Study of Liver Diseases (AASLD) if you have liver scarring (cirrhosis).
  • If you do not have cirrhosis, a tissue test (histology) is required to confirm the cancer, and the tumor must not be treatable with curative surgery or local treatments (called locoregional therapies), or it must have gotten worse after such treatments.
  • Your overall health and ability to carry out daily activities must be rated as 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale, measured within the week before you join the study.
  • Your liver function must be classified as Child‑Pugh class A (the best category) based on tests done within the week before randomization.
  • You need to have a life expectancy of at least 12 weeks (about three months) at the time of enrollment.
  • If you have an active hepatitis B infection, your blood level of hepatitis B virus DNA must be less than 500 international units per milliliter (IU/mL), measured within 28 days before starting treatment, and you must have been taking hepatitis B medicine (such as entecavir) for at least 14 days and be willing to continue it for the length of the study.
  • Both men and women can participate, and the study includes adult participants (typically age 18 years or older).

Who cannot join the trial?

6 criteria

  • Having symptoms from untreated or worsening central nervous system metastases (cancer that has spread to the brain or spinal cord) – you cannot join.
  • Having a past history of leptomeningeal disease (cancer cells in the thin layers covering the brain and spinal cord) or hepatic encephalopathy (confusion caused by severe liver disease) – you cannot join.
  • Having had any other type of cancer (not liver cancer) within the last five years – you cannot join.
  • Having had a serious cardiovascular disease (such as a heart attack, severe heart failure, or stroke) in the past three months – you cannot join.
  • Having a known severe allergy or hypersensitivity to any of the study drugs or their ingredients – you cannot join.
  • Having received any other experimental drug treatment (investigational therapy) within the last 28 days – you cannot join.
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Investigated drugs

  • Atezolizumab

    is an immunotherapy medicine that helps the body’s immune system see and attack liver cancer cells. In this study it is given through an IV infusion, where the drug is slowly dripped into a vein over a short period of time.

  • Sorafenib

    is a targeted oral tablet that blocks several proteins that tumors use to grow and spread. By stopping these signals, sorafenib can slow the growth of liver cancer and may help keep the disease from getting worse.

  • Lenvatinib

    is an oral capsule that works as a targeted therapy. It blocks proteins that help new blood vessels form and that support tumor growth, which can limit the tumor’s ability to grow and spread.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is given by IV infusion as a solution for infusion; it is an approved drug that is widely studied in cancer treatment. It is used for unresectable hepatocellular carcinoma and other solid tumors. It works by blocking the PD‑L1 protein, allowing the immune system to recognize and attack cancer cells. It belongs to the class of immune checkpoint inhibitors.

  • Sorafenib

    Sorafenib is taken by mouth as film‑coated tablets; it is an approved medication that has been used for many years in liver cancer and is well described in the literature. It is indicated for unresectable hepatocellular carcinoma and also for kidney and thyroid cancers. It blocks several kinases that drive tumor growth and the formation of new blood vessels, slowing cancer spread. It is classified as a multikinase (tyrosine kinase) inhibitor.

  • Lenvatinib

    Lenvatinib is taken by mouth as hard capsules; it is an approved drug that has been studied extensively for liver and thyroid cancers. It is used for unresectable hepatocellular carcinoma and other solid tumors. It inhibits multiple kinases involved in tumor growth and blood vessel development, reducing the tumor’s ability to grow. It belongs to the class of multikinase (tyrosine kinase) inhibitors.

Investigated diseases

Unresectable hepatocellular carcinoma - Unresectable hepatocellular carcinoma is a type of liver cancer that cannot be removed surgically because it is too large or positioned near critical structures. The disease starts when liver cells grow abnormally and form a tumor. Over time, the tumor can enlarge, spread within the liver, and may reduce the liver’s ability to work properly. As it advances, the cancer can also spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503229-21-00Protocol codeMO42541Estimated enrolment554 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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