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

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What is this study about?

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.

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 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 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 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 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 end of treatment

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

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
KBC Zagreb Zagreb Croatia
Hopital Saint Antoine Paris France
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
North Estonia Medical Centre Foundation Tallin Estonia
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Tampere University Hospital Tampere Finland
Tartu University Hospital Tartu Estonia
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Son Llatzer Palma Spain
Centre Hospitalier Universitaire De Nantes Nantes France
University Medical Center Ljubljana Ljubljana Slovenia
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
San Camillo Forlanini Hospital Rome Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Hospital Paul Brousse Villejuif France
Klinik Favoriten Vienna Austria
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Cyjytrcpg Utjxlrocwknhbz Sjfguffns Woluwe-Saint-Lambert Belgium
Phlq Twxxh Hgbwffql Ulugkgvsvlqd Sabadell Spain
Dnwjukvs Om Helsinki Finland
Hplcmqkj Vusy dnyhsvep Barcelona Spain
Adohjjtoae Pzlvkyek Hmtcsles Du Mljttkoxe Marseille France
Camw Do Ninmv Vandoeuvre Les Nancy France
Garpfv Uwrjdswfnh Fsdbtrjzx Frankfurt Germany
Ayzqwqq Ueukv Sxhepsoge Lxnvpc Dl Blyzllx Bologna Italy
Ihhesp Bonheiden Belgium

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
26.08.2021
Belgium Belgium
Not recruiting
26.08.2021
Bulgaria Bulgaria
Not recruiting
26.08.2021
Croatia Croatia
Not recruiting
26.08.2021
Estonia Estonia
Not recruiting
26.08.2021
Finland Finland
Not recruiting
26.08.2021
France France
Not recruiting
26.08.2021
Germany Germany
Not recruiting
26.08.2021
Greece Greece
Not recruiting
26.08.2021
Italy Italy
Not recruiting
26.08.2021
Slovenia Slovenia
Not recruiting
26.08.2021
Spain Spain
Not recruiting
26.08.2021

Trial locations

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.

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 ID:
2023-503229-21-00
Protocol code:
MO42541
Trial Phase:
Therapeutic confirmatory (Phase III)

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