A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Launched by HOFFMANN-LA ROCHE · Feb 23, 2021
Trial Information
Current as of April 29, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the combination of a medication called atezolizumab with either lenvatinib or sorafenib, compared to using lenvatinib or sorafenib alone. The goal is to see if adding atezolizumab improves treatment outcomes for patients with a type of liver cancer known as unresectable hepatocellular carcinoma (HCC) who have not responded well to earlier treatments. Participants in this study will be those whose disease has progressed after receiving a previous combination treatment of atezolizumab and another drug called bevacizumab.
To be eligible for the trial, patients should have advanced liver cancer that cannot be removed with surgery and must have experienced disease progression after at least four cycles of the earlier treatment. Other criteria include having measurable tumors that haven't been treated with local therapies and maintaining certain health standards, such as being able to perform daily activities. Throughout the trial, participants will receive regular check-ups and assessments to monitor their health and the effectiveness of the treatment. This study is currently not recruiting new patients, but it is important for eligible individuals to know about this opportunity to potentially receive a new combination therapy that could improve their condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
- • Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR).
- • At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
- • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization
- • Child-Pugh class A within 7 days prior to randomization
- • Adequate hematologic and end-organ function
- Exclusion Criteria:
- • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- • History of leptomeningeal disease
- • History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days
- • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonton, Alberta, Canada
Villejuif, , France
Zaragoza, , Spain
Seoul, , Korea, Republic Of
Gent, , Belgium
Madrid, , Spain
Bruxelles, , Belgium
Guangzhou, , China
Tianjin, , China
Turku, , Finland
Petach Tikva, , Israel
Valencia, , Spain
Bangkok, , Thailand
Porto Alegre, Rs, Brazil
Hamilton, Ontario, Canada
Hiroshima, , Japan
Valencia, , Spain
London, , United Kingdom
Aichi, , Japan
Hannover, , Germany
Cordoba, , Spain
Ulm, , Germany
Edmonton, Alberta, Canada
Seoul, , Korea, Republic Of
Leuven, , Belgium
Beijing, , China
Shanghai, , China
Seoul, , Korea, Republic Of
Bangkok, , Thailand
Madrid, , Spain
Haifa, , Israel
Palma De Mallorca, , Spain
Lille, , France
Ljubljana, , Slovenia
Mainz, , Germany
Zagreb, , Croatia
Shanghai, , China
Chiba, , Japan
Petach Tikva, , Israel
Seoul, , Korea, Republic Of
Brasschaat, , Belgium
Innsbruck, , Austria
Zaragoza, , Spain
Bangkok, , Thailand
Osaka, , Japan
Bonheiden, , Belgium
Kanagawa, , Japan
Guangzhou, , China
Newcastle Upon Tyne, , United Kingdom
Pessac, , France
Harbin, , China
Nanjing City, , China
Goyang Si, , Korea, Republic Of
Tübingen, , Germany
Tartu, , Estonia
Chiba, , Japan
Tochigi, , Japan
Chandigarh, , India
Tokyo, , Japan
Jinan, , China
Calgary, Alberta, Canada
Makati City, , Philippines
Salvador, Ba, Brazil
Tartu, , Estonia
Santiago De Compostela, La Coruña, Spain
Palma De Mallorca, Islas Baleares, Spain
Shenyang, , China
Vandoeuvre Les Nancy, , France
Villejuif, , France
Beijing, , China
Izmir, , Turkey
Firenze, Toscana, Italy
Roeselare, , Belgium
Mumbai, Maharashtra, India
Padova, Veneto, Italy
Tainan, , Taiwan
Athens, , Greece
Tübingen, , Germany
Hefei, , China
Jinan, , China
Brasilia, Df, Brazil
Hangzhou, , China
Moscow, , Russian Federation
Madrid, , Spain
Cebu City, , Philippines
Bruxelles, , Belgium
Fukuoka, , Japan
Hannover, , Germany
Nantes, , France
Liverpool, , United Kingdom
Manchester, , United Kingdom
Milano, Lombardia, Italy
Osaka, , Japan
Barcelona, , Spain
Porto Alegre, Rs, Brazil
Pisa, Toscana, Italy
Riyadh, , Saudi Arabia
Sihhiye/Ankara, , Turkey
Oxford, , United Kingdom
Rio De Janeiro, Rj, Brazil
Plovdiv, , Bulgaria
Madrid, , Spain
London, , United Kingdom
Toronto, Ontario, Canada
Bursa, , Turkey
Varna, , Bulgaria
Ulm, , Germany
Chengdu, , China
Athens, , Greece
Thessaloniki, , Greece
Porto Alegre, Rio Grande Do Sul, Brazil
Jinan, , China
San José, , Costa Rica
Belo Horizonte, Mg, Brazil
Toulouse Cedex 09, , France
Roma, Lazio, Italy
Roma, Lazio, Italy
Frankfurt, , Germany
London, , United Kingdom
Marseille, , France
Madrid, , Spain
Napoli, Campania, Italy
Sofia, , Bulgaria
San José, , Costa Rica
San Jose, , Costa Rica
Hefei, , China
Osaka, , Japan
Adana, , Turkey
Haifa, , Israel
Changsha City, , China
Wuhan City, , China
Chelyabinsk, Moskovskaja Oblast, Russian Federation
Tokyo, , Japan
San Jose, , Costa Rica
Gyeonggi Do, , Korea, Republic Of
Oxford, , United Kingdom
São Paulo, Sp, Brazil
Pasig City, , Philippines
Tel Aviv, , Israel
St. Pölten, , Austria
Putrajaya, Fed. Territory Of Kuala Lumpur, Malaysia
Cairo, , Egypt
Madrid, , Spain
Nice Cedex, , France
Frankfurt, , Germany
Zhongzheng Dist., , Taiwan
Ankara, , Turkey
Panagyurishte, , Bulgaria
Tallinn, , Estonia
Salzburg, , Austria
Porto Alegre, Rs, Brazil
Madrid, , Spain
Chengdu City, , China
Plovdiv, , Bulgaria
Santiago, , Chile
Yudino, Moskovskaja Oblast, Russian Federation
Ljubljana, , Slovenia
Paris, , France
Gachibowli, Telangana, India
Wien, , Austria
Hyogo, , Japan
Moskva, Moskovskaja Oblast, Russian Federation
Istanbul, , Turkey
Porto Alegre, Rio Grande Do Sul, Brazil
Napoli, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Torino, Piemonte, Italy
Palermo, Sicilia, Italy
Fuzhou City, , China
Mainz, , Germany
Bakirkoy / Istanbul, , Turkey
Marseille, , France
Sabadell, Barcelona, Spain
Pamplona/Iruña, Navarra, Spain
Cordoba, , Spain
Madrid, , Spain
Cebu City, , Philippines
Napoli, Campania, Italy
Pesochny, Sankt Petersburg, Russian Federation
Leuven, Vl Brabant, Belgium
Florianopolis, Sc, Brazil
Santiago, , Chile
Santiago, , Chile
Guangzhou City, , China
Helsinki, , Finland
Tampere, , Finland
Montpellier, , France
Esslingen, , Germany
Nea Kifissia, , Greece
Thessaloniki, , Greece
Petaling Jaya, Selangor, Selangor, Malaysia
Kuala Lumpur, , Malaysia
Moscow, Moskovskaja Oblast, Russian Federation
Moskva, Moskovskaja Oblast, Russian Federation
Bern, , Switzerland
Zürich, , Switzerland
üsküdar, , Turkey
London, , United Kingdom
Grenoble Cedex 9, , France
Rennes, , France
Guangzhou City, , China
Hefei City, , China
Innsbruck, , Austria
St. Pölten, , Austria
Sao Paulo, Sp, Brazil
Pasig City, , Philippines
Sofia, , Bulgaria
Roma, Lazio, Italy
Petah Tikva, , Israel
Seoul, , Korea, Republic Of
Wien, , Austria
Palermo, Sicilia, Italy
üsküdar, , Turkey
Moscow, , Russian Federation
Beijing City, , China
Adana, , Turkey
Birmingham, , United Kingdom
Florianopolis, Santa Catarina, Brazil
Florianopolis, Sc, Brazil
Moscow, Moskovskaja Oblast, Russian Federation
Banglore, Karnataka, India
Kuala Lumpur, Fed. Territory Of Kuala Lumpur, Malaysia
Newcastle Upon Tyne, , United Kingdom
Rome, Lazio, Italy
Palermo, Sicilia, Italy
Hangzhou City, , China
Panagyurishte, , Bulgaria
Santiago De Compostela, La Coruna, Spain
Salzburg, , Austria
Firenze, Toscana, Italy
Sihhiye/Ankara, , Turkey
Manchester, , United Kingdom
Pisa, Toscana, Italy
São Paulo, , Brazil
Padova, Veneto, Italy
Rio De Janeiro, , Brazil
Bursa, , Turkey
Izmir, , Turkey
Bangkok, , Thailand
Zhongzheng Dist., , Taiwan
Tainan, , Taiwan
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Pamplona/Iruña, Navarra, Spain
Istanbul, , Turkey
Tel Aviv, , Israel
Calgary, Alberta, Canada
Belo Horizonte, Minas Gerais, Brazil
Cairo, , Egypt
Tallinn, , Estonia
Tampere, , Finland
Grenoble Cedex 9, , France
Rennes, , France
Nea Kifissia, , Greece
Napoli, Campania, Italy
Milano, Lombardia, Italy
Kuala Lumpur, Fed. Territory Of Kuala Lumpur, Malaysia
Moscow, Moskovskaja Oblast, Russian Federation
Zürich, , Switzerland
Ba?C?Lar, , Turkey
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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