Study on Cabozantinib and Atezolizumab vs. Sorafenib for Advanced Liver Cancer in Patients Without Prior Treatment
Sponsor: Exelixis
ClinicalTrials ID:NCT03755791
This clinical trial is comparing the effectiveness and safety of a new combination treatment using cabozantinib and atezolizumab against the standard treatment, sorafenib, in adults with advanced liver cancer who have not received previous systemic anticancer therapy.
Patient Parameters
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Program Overview
The purpose of this Phase 3 study is to evaluate how well the combination of cabozantinib and atezolizumab works compared to the standard treatment, sorafenib, in adults with advanced liver cancer (hepatocellular carcinoma) who have not had any previous systemic anticancer treatments. The study will also look at how cabozantinib alone performs in terms of safety and effectiveness.
Description
This study involves multiple centers and is a randomized, open-label trial, meaning participants will be randomly assigned to receive either the combination of cabozantinib and atezolizumab or the standard treatment, sorafenib. The main goal is to see if the combination treatment can help patients live longer without their cancer getting worse and improve overall survival compared to sorafenib. Additionally, the study will assess how well cabozantinib alone works compared to sorafenib in this group of patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced liver cancer (HCC) based on specific medical guidelines.
- Cancer cannot be treated with surgery, transplant, or other local therapies.
- Have measurable cancer as determined by medical scans.
- Classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C.
- Have a Child-Pugh Score of A, indicating good liver function.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have a specific type of liver cancer such as fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma.
- Have received any prior systemic anticancer therapy for advanced liver cancer.
- Have had radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 8 weeks before starting the study.
- Have untreated or unstable brain metastases unless treated and stable for at least 8 weeks.
- Are taking oral blood thinners.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Exelixis Clinical Site #208 | 85004 | Phoenix | Arizona |
| Exelixis Clinical Site #159 | 85719 | Tucson | Arizona |
| Exelixis Clinical Site #44 | 92037 | La Jolla | California |
| Exelixis Clinical Site #112 | 90033 | Los Angeles | California |
| Exelixis Clinical Site #200 | 92868-3201 | Orange | California |
| Exelixis Clinical Site #2 | 92377 | Rialto | California |
| Exelixis Clinical Site #207 | 92093 | San Diego | California |
| Exelixis Clinical Site #109 | 94115 | San Francisco | California |
| Exelixis Clinical Site #54 | 94158 | San Francisco | California |
| Exelixis Clinical Site #58 | 20007 | Washington D.C. | District of Columbia |
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