Study on Atezolizumab and Bevacizumab for Patients with Intermediate-Stage Liver Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of liver cancer known as intermediate-stage hepatocellular carcinoma. The trial is investigating the effectiveness and safety of a combination of two medications, atezolizumab and bevacizumab, compared to a procedure called transarterial chemoembolization, or TACE. Atezolizumab, also known by its code name RO5541267, and bevacizumab are both given as solutions for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to determine how well the combination of these medications works in treating this stage of liver cancer and to compare it with the existing treatment method, TACE. Participants in the study will receive either the combination of atezolizumab and bevacizumab or undergo the TACE procedure. The study will monitor various aspects such as the time it takes for the treatment strategy to fail, overall survival rates, and the response of the cancer to the treatment. The study will also look at the safety of the treatments and how they affect the quality of life of the participants.

The trial is expected to run for several years, with an estimated end date in 2027. Participants will be closely monitored throughout the study to assess the effectiveness of the treatments and any potential side effects. The goal is to find a more effective treatment option for patients with this type of liver cancer, potentially improving their outcomes and quality of life.

1 joining the study

Upon joining the study, the patient is required to provide a signed informed consent form. This document confirms the patient’s understanding and agreement to participate in the trial.

The patient must meet specific laboratory criteria, including acceptable levels of bilirubin and protein in urine, among others, to ensure eligibility for the trial.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of intermediate-stage hepatocellular carcinoma. This may involve imaging tests such as CT or MRI scans.

The patient’s medical history is reviewed to ensure there are no severe comorbidities or untreated conditions that could interfere with the trial.

3 treatment administration

The patient receives treatment with atezolizumab and bevacizumab, both administered as solutions for infusion through an intravenous route.

The specific dosage and frequency of administration are determined by the trial protocol and the patient’s individual health status.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment and to identify any potential side effects.

Follow-up visits are scheduled to evaluate the patient’s overall health, liver function, and progression of the disease.

5 end of treatment

The treatment phase concludes based on the trial’s duration or if the patient experiences significant changes in health status.

Final assessments are performed to determine the effectiveness of the treatment and to document any lasting effects.

Who Can Join the Study?

  • Must have signed an Informed Consent Form, which means you agree to participate in the study after understanding all the details.
  • Must have certain laboratory test results within normal limits or not too abnormal, including tests for liver function, kidney function, and blood components.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • No untreated or partially treated varices, which are swollen veins that can bleed, as confirmed by a recent medical examination.
  • No other severe health conditions that could interfere with the study.
  • Any side effects from previous treatments must be mild or resolved, except for hair loss.
  • If you have active hepatitis B, your virus levels must be low, and you must be on treatment for at least 14 days before starting the study.
  • If you have active hepatitis C, you can participate if you have been treated before the study, but not during the study.
  • Women who can have children must agree to use effective birth control or not have heterosexual intercourse during the study and for a certain period after the study ends.
  • Men must agree to use birth control methods with partners who can have children and not donate sperm during the study and for a certain period after the study ends.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of hepatocellular carcinoma, a type of liver cancer, based on specific medical tests.
  • Must have intermediate-stage liver cancer that cannot be treated with surgery or liver transplant but can be treated with a procedure called TACE.
  • Can have cancer that has come back after previous treatments if more TACE is needed.
  • Must have a Child-Pugh score of class A or B7, which is a way to measure liver function, without needing high doses of a medication called spironolactone.
  • Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can still do light work.
  • Must have adequate organ and bone marrow function, meaning your organs and bone marrow are working well enough.
  • Must have a life expectancy of at least 3 months.

Who Cannot Join the Study?

  • Patients with other types of cancer besides intermediate-stage liver cancer cannot participate.
  • Patients who have had previous treatments that might interfere with the study cannot participate.
  • Patients with severe heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with any other serious medical conditions that might affect the study cannot participate.

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
Krankenhaus Nordwest GmbH Frankfurt Germany
Hopitaux Universitaires Pitie Salpetriere Paris France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Universitario De Jaen Jaen Spain
Klinikum St Marien Amberg Amberg Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
St. Josefs-Hospital Wiesbaden GmbH Wiesbaden Germany
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier D Avignon Avignon France
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universita’ Di Pisa Pisa Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum Konstanz GmbH Konstanz Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Institut Sainte Catherine Avignon France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hôpital Universitaire Paul Brousse Villejuif France
Universitätsklinikum St. Pölten St. Poelten Austria
Udhliavxfrsbvjqoxnxwk Kamcqzpfguudahwybpbukms Beytng Gusv Bochum Germany
Hzrorlfu Uctgvhaldoepz Mooqkfh Db Viqqnwuutg Santander Spain
Hgsecmoy Uepbjxgysjkme Dp Bovjibe Badajoz Spain
Uscpyuayti Hjmfmrbr Cavdfvj Cologne Germany
Ixexeaek Remafytxd Pyz Lt Sdeotc Dwb Tmuvzc Dngg Atousfo Ihpr Sogyjl Meldola Italy
Uhqghmztgoepgljtvhycb Dckouexhpul Awl Duesseldorf Germany
Mtrouty Ukvkcbezwx Ok Guzv Graz Austria
Gwqctp Ufhuthpmte Fcozbozuo Frankfurt Germany
Utwoimjluobgdsjlaojhi Wjimwprqw Azi Wuerzburg Germany
Amreyjt Urdee Sttwsewbk Lnqeur Do Brnsicw Bologna Italy
Hiyezzia Unfewdqhgqvzb Hgqafrvz Tiisn y Pbcepv Itfpcwke Cggklv dtivimppxkbwquvzk (oopy Badalona Spain
Hptaukzd Vwzv dwkwmwqu Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
22.10.2021
France France
Recruiting
22.10.2021
Germany Germany
Recruiting
22.10.2021
Italy Italy
Recruiting
22.10.2021
Spain Spain
Recruiting
22.10.2021

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the body’s immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

Bevacizumab is another medication used in combination with atezolizumab. It works by blocking the growth of new blood vessels that tumors need to grow and spread. This helps to slow down or stop the growth of cancer.

Transarterial Chemoembolization (TACE) is a procedure used in this trial as a comparison to the medications. It involves delivering chemotherapy directly to the liver tumor through the blood vessels, while also blocking the blood supply to the tumor. This helps to shrink the tumor and limit its growth.

Investigated diseases:

Intermediate-stage Hepatocellular Carcinoma – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. It is considered intermediate-stage when the cancer has not spread to distant parts of the body but may have grown into nearby blood vessels or lymph nodes. Patients at this stage often have multiple tumors in the liver, and the liver function is usually still adequate. The disease progresses as the tumors grow larger or increase in number, potentially affecting liver function over time. Symptoms may include abdominal pain, weight loss, and jaundice, although some individuals may not experience noticeable symptoms initially. The progression can vary, and monitoring is essential to manage the condition effectively.

Trial ID:
2024-512953-26-00
Protocol code:
ABC-HCC
NCT ID:
NCT04803994
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of belzutifan and lenvatinib for patients with von Hippel-Lindau disease-associated tumors or other specific solid tumors.

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +4
  • Long-term Safety Study of Vusolimogene Oderparepvec, RP2, and RP3 in Patients with Melanoma, Liver Cancer, or Advanced Solid Tumors

    Recruiting

    3 1 1
    France Germany Greece Poland Spain