Search / Trial NCT03755791

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy
Launched by EXELIXIS · Nov 26, 2018

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Trial Information

Current as of April 27, 2025

Active, not recruiting

Keywords

Liver Cancer Hepatocellular Carcinoma

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with advanced hepatocellular carcinoma (HCC), which is a type of liver cancer. The study is comparing the effectiveness and safety of two treatments: a combination of two drugs called cabozantinib and atezolizumab versus the standard treatment, sorafenib. Participants who have not yet received any systemic cancer therapy may be eligible if they have been diagnosed with HCC and their cancer cannot be treated with surgery or other local therapies. The study is looking for adults aged 65 to 74 who meet certain health criteria, such as having a specific type of liver function and cancer staging.

If you are considering participating in this trial, you would receive either the combination treatment or sorafenib, depending on which group you are assigned to. There will also be a group receiving only cabozantinib to help researchers understand how well it works on its own. The study is currently active but not recruiting new participants. It’s important to know that certain conditions, like prior cancer treatments or specific types of liver cancer, may prevent eligibility. Overall, this trial aims to find better treatment options for those battling advanced liver cancer.

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.
• The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
• Measurable disease per RECIST 1.1 as determined by the Investigator.
• Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
• Child-Pugh Score of A.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
• Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
• Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy within ≥ 28 days before randomization
• Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization.
• Concomitant anticoagulation with oral anticoagulants

About Exelixis

Exelixis, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of cancer. With a commitment to advancing precision medicine, Exelixis leverages its expertise in small molecule drug discovery to address unmet medical needs in oncology. The company's robust pipeline includes a range of investigational compounds targeting various cancer types, supported by rigorous clinical trials that aim to improve patient outcomes. Through collaboration and a patient-centric approach, Exelixis strives to deliver transformative therapies that enhance the quality of life for those affected by cancer.

Locations

Phoenix, Arizona, United States

Tucson, Arizona, United States

La Jolla, California, United States

Los Angeles, California, United States

Orange, California, United States

Rialto, California, United States

San Diego, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Burlington, Massachusetts, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Las Vegas, Nevada, United States

New Brunswick, New Jersey, United States

Albuquerque, New Mexico, United States

Chapel Hill, North Carolina, United States

Toledo, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Temple, Texas, United States

Seattle, Washington, United States

Spokane, Washington, United States

City Of Buenos Aires, Buenos Aires, Argentina

Pilar, Buenos Aires, Argentina

Rosario, Santa Fe, Argentina

Camperdown, New South Wales, Australia

Darlinghurst, New South Wales, Australia

Kingswood, New South Wales, Australia

Kogarah, New South Wales, Australia

Westmead, New South Wales, Australia

Greenslopes, Queensland, Australia

Kurralta Park, South Australia, Australia

Box Hill, Victoria, Australia

Heidelberg, Victoria, Australia

Parkville, Victoria, Australia

Nedlands, Western Australia, Australia

Klagenfurt, Kärnten, Austria

St. Pölten, Lower Austria, Austria

Linz, Oberosterreich, Austria

Graz, Steiermark, Austria

Wien, , Austria

Brussels, California, Belgium

Brussels, , Belgium

Edegem, , Belgium

Gent, , Belgium

Haine Saint Paul, , Belgium

Leuven, , Belgium

Liège, , Belgium

Salvador, Ba, Brazil

Belo Horizonte, Mg, Brazil

Curitiba, Pr, Brazil

Porto Alegre, Rs, Brazil

Barretos, Sp, Brazil

Jaú, Sp, Brazil

São Paulo, Sp, Brazil

São Paulo, , Brazil

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Winnipeg, Manitoba, Canada

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Montréal, Quebec, Canada

Hefei, Anhui, China

Fuzhou, Fujian, China

Xiamen, Fujian, China

Guangzhou, Guangdong, China

Harbin, Heilongjiang, China

Zhengzhou, Henan, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Nantong, Jiangsu, China

Nanchang, Jiangxi, China

Jiangyin, Jiansu, China

Changchun, Jilin, China

Shenyang, Liaoning, China

Linyi, Shandong, China

Chengdu, Sichuan, China

Hangzhou, Zhejiang, China

Beijing, , China

Shanghai, , China

Montería, Cordoba, Colombia

Hradec Králové, , Czechia

Olomouc, , Czechia

Praha 4, , Czechia

Praha 5, , Czechia

Amiens, , France

Besancon, , France

Bondy Cedex, , France

Caen Cedex 09, , France

Clichy, , France

Grenoble, , France

Lille Cedex, , France

Lyon Cedex 4, , France

Montbeliard, , France

Montpellier, , France

Nantes, , France

Nice, , France

Pessac, , France

Vandœuvre Lès Nancy, , France

Batumi, , Georgia

Tbilisi, , Georgia

Frankfurt, Hessen, Germany

Kassel, Hessen, Germany

Berlin, , Germany

Hamburg, , Germany

Hong Kong, , Hong Kong

Budapest, , Hungary

Debrecen, , Hungary

Szeged, , Hungary

Dublin, , Ireland

Jerusalem, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Tricase, Lecce, Italy

Rozzano, Milano, Italy

Bologna, , Italy

Brescia, , Italy

Milan, , Italy

Napoli, , Italy

Novara, , Italy

Roma, , Italy

Torino, , Italy

Udine, , Italy

Goyang Si, Gyeonggi Do, Korea, Republic Of

Suwon, Gyeonggi Do, Korea, Republic Of

Busan, , Korea, Republic Of

Incheon, , Korea, Republic Of

Seoul, , Korea, Republic Of

Tuxtla Gutiérrez, Chiapas, Mexico

León, Guanajuato, Mexico

Monterrey, Nuevo Leon, Mexico

Ciudad De México, , Mexico

Mexico City, , Mexico

San Luis Potosí, , Mexico

Veracruz, , Mexico

Maastricht, Limburg, Netherlands

Amsterdam, Noord Holland, Netherlands

Rotterdam, Zuid Holland, Netherlands

Utrecht, , Netherlands

Grafton, Auckland, New Zealand

Newton, Wellington, New Zealand

Cebu City, , Philippines

Pasig City, , Philippines

Quezon City, , Philippines

Warszawa, Mazowieckie, Poland

Gdansk, Pomorskie, Poland

Mysłowice, Slaskie, Poland

Cluj Napoca, Cluj, Romania

Bucuresti, , Romania

Iaşi, , Romania

Kislino, Kursk Region, Russian Federation

Kaluga, , Russian Federation

Krasnodar, , Russian Federation

Moscow, , Russian Federation

Murmansk, , Russian Federation

Nizhny Novgorod, , Russian Federation

Saint Petersburg, , Russian Federation

Sochi, , Russian Federation

Singapore, , Singapore

Santander, Cantabria, Spain

Majadahonda, Madrid, Spain

Pamplona, Navarra, Spain

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Zaragoza, , Spain

Basel, , Switzerland

Bern, , Switzerland

Saint Gallen, , Switzerland

Zurich, , Switzerland

Changhua, , Taiwan

Kaohsiung, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Tainan, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Pathum Wan, Bangkok, Thailand

Muang, Khon Kaen, Thailand

Hat Yai, Songkla, Thailand

Chiang Mai, , Thailand

Istanbul, Instanbul, Turkey

Ankara, , Turkey

Edirne, , Turkey

Istanbul, , Turkey

Malatya, , Turkey

Chernivtsi, , Ukraine

Dnipro, , Ukraine

Kharkiv, , Ukraine

Odesa, , Ukraine

Uzhhorod, , Ukraine

Bristol, England, United Kingdom

Cambridge, England, United Kingdom

London, England, United Kingdom

Manchester, England, United Kingdom

Belfast, Northern Ireland, United Kingdom

Khon Kaen, , Thailand

Patients applied

0 patients applied

Timeline

First submit

November 26, 2018

Trial launched

June 10, 2018

Trial updated

March 20, 2024

Estimated completion

Not reported

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Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy Launched by EXELIXIS · Nov 26, 2018

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy
Launched by EXELIXIS · Nov 26, 2018