A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy
- Conditions
- Hepatocellular carcinoma
- Registration Number
- 2024-516479-34-00
- Lead Sponsor
- Exelixis Inc.
- Brief Summary
The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 7
Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by multiphase imaging using CT or MRI per the American Association for the Study of Liver Diseases (AASLD) guidelines or European Association for the Study of the Liver (EASL 2018)
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.
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 ICIs. Subjects who have received local intratumoral or arterial chemotherapy are eligible. Subjects who have received any local anticancer therapy within 28 days prior to randomization are ineligible
Radiation therapy for bone metastasis within 2 weeks, any other external beam 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of Progression Free Survival (PFS) per RECIST 1.1, by Blinded Independent Radiology Committee (BIRC) for the experimental arm (cabozantinib+atezolizumab) vs the control arm ( sorafenib) Duration of Progression Free Survival (PFS) per RECIST 1.1, by Blinded Independent Radiology Committee (BIRC) for the experimental arm (cabozantinib+atezolizumab) vs the control arm ( sorafenib)
Duration of Overall Survival (OS) for the experimental arm (cabozantinib+atezolizumab) vs the control arm (sorafenib) Duration of Overall Survival (OS) for the experimental arm (cabozantinib+atezolizumab) vs the control arm (sorafenib)
- Secondary Outcome Measures
Name Time Method PFS per RECIST 1.1 by BIRC for the single-agent cabozantinib arm vs the control arm (sorafenib) PFS per RECIST 1.1 by BIRC for the single-agent cabozantinib arm vs the control arm (sorafenib)
Trial Locations
- Locations (6)
Centre Hospitalier Universitaire De Liege
🇧🇪Liege, Belgium
CHRU De Nancy
🇫🇷Vandoeuvre Les Nancy, France
University Of Debrecen
🇭🇺Debrecen, Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Hospital Universitario Puerta De Hierro De Majadahonda
🇪🇸Majadahonda, Spain
Institut Catala D'oncologia
🇪🇸L'hospitalet De Llobregat, Spain
Centre Hospitalier Universitaire De Liege🇧🇪Liege, BelgiumJean DelwaideSite contact+3243667256jean.delwaide@chuliege.be