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About the PHOCUS Trial

The PHOCUS Trial is a Phase 3 trial evaluating an investigational drug called Pexa-Vec (JX-594), to determine if it can slow the progression of advanced liver cancer and improve quality of life.

This research study is for people with advanced liver cancer who have never received systemic medicine (affecting the entire body) for advanced liver cancer. Liver cancer (also called hepatocellular carcinoma or HCC) is a cancer that originates from your liver (not a cancer that started in a different organ of your body and spread to your liver). Sorafenib (Nexavar®) is the only approved systemic medicine for advanced liver cancer.

All study participants will receive sorafenib. Patients will also receive additional medical examinations and assessments to help the study doctor and the study staff monitor participants' health. These study-specific treatments, exams and assessments will be provided to study participants at no cost (provided by the sponsor of the study).

Eligible study participants will be randomly assigned to one of two treatment groups. They will have a 50% chance of receiving the investigational therapy plus sorafenib and a 50% chance of receiving the sorafenib alone. To determine if you are eligible, the study doctor and his or her staff will conduct medical examinations to evaluate your current health.

During this time, you will randomly be assigned to one of the following two treatment groups:

Pexa-Vec (Investigational Therapy)
plus Sorafenib
  • Up to 3 treatments with the investigational therapy Pexa-Vec
  • Treatment with sorafenib – a pill that is taken orally every day at home
  • Examinations and assessments to check the status of your cancer and overall health including quality of life
  • Frequent follow-up (in person visits to the study site and phone calls)
Sorafenib alone
  • Treatment with sorafenib — a pill that is taken orally every day at home
  • Examinations and assessments to check the status of your cancer and overall health including quality of life
  • Frequent follow-up (in person visits to the study site and phone calls)

Investigational therapy treatment will be given at a trial center; this is a clinic or a hospital where the trial is being conducted.