Study on Cabozantinib and Atezolizumab vs. Sorafenib for Advanced Liver Cancer

Sponsor: Exelixis

Sponsor score: 40

ClinicalTrials ID:NCT03755791

Provider View

This clinical trial is comparing two treatments for adults with advanced liver cancer (HCC) who have not received previous systemic anticancer therapy. The study aims to determine if a combination of cabozantinib and atezolizumab is more effective than the standard treatment with sorafenib.

Patient Parameters

Program Overview

This Phase 3 study is testing whether a combination of two drugs, cabozantinib and atezolizumab, can improve outcomes for adults with advanced liver cancer (HCC) compared to the standard treatment with sorafenib. The study will also look at how well cabozantinib works on its own. Participants will be randomly assigned to receive either the combination treatment or sorafenib, and researchers will monitor their progress to see which treatment helps patients live longer without the cancer getting worse.

Description

This study involves adults with advanced liver cancer (HCC) who have not yet received systemic anticancer therapy. The main goal is to see if the combination of cabozantinib and atezolizumab can help patients live longer and keep the cancer from progressing compared to the standard treatment with sorafenib. The study will also evaluate how effective cabozantinib is when used alone. Participants will be randomly assigned to one of the treatment groups and will receive regular check-ups to monitor their health and the cancer's response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (HCC) based on specific medical guidelines.
  • Cancer cannot be treated with surgery, transplant, or local therapies like ablation.
  • Have measurable cancer as determined by medical scans.
  • Classified as stage B or C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
  • 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 or mixed types.
  • Have received previous systemic anticancer therapy for advanced liver cancer.
  • Have had recent radiation therapy for bone metastasis or other areas.
  • Have untreated or unstable brain metastases.
  • Are taking certain blood-thinning medications.

Note: Additional criteria may apply as defined by the study protocol.

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