A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma

Protocol No
AZ-D933GC00001-EMERALD-1
Principal Investigator
Aditya Shreenivas
Phase
III
Summary
AstraZeneca is doing this research to find out if the medication called Durvalumab will work and be safe for the treatment of locoregional HCC in combination with TACE treatments either by itself or with another medication called Bevacizumab. Durvalumab has been approved by the FDA as therapy for the treatment of locally advanced or metastatic urothelial carcinoma, for patients whose cancers progressed during or after platinum-based chemotherapy. Durvalumab has also been approved by the FDA and the European Medicines Agency (EMA) for the treatment of patients with locally advanced non-small cell lung cancer after chemoradiation therapy. Both Durvalumab and Bevacizumab are still in the development stage for the treatment of HCC. Neither are approved for treatment of HCC, except for use in research studies like this. TACE is a procedure that blocks or slows down the blood supply to the cancer and delivers chemotherapy directly to the tumor so that the cancer cells die. TACE is done by injecting a material through a thin tube (called a catheter) into the large blood vessels that are feeding the tumor. The material blocks the arteries and delivers chemotherapy to the tumor. There are two types of TACE are used for this study, conventional TACE (cTACE) and drug-eluding-bead TACE (DEB-TACE). There may be a restriction in the number of participants that undergo conventional TACE and if so, your study doctor will inform you. It's up to your physician to decide which kind of TACE is right for you. Your doctor will inform you if you receive conventional or DEB-TACE. Researchers have found that sometimes the body's own immune system may slow down or prevent cancer growth. Sometimes, though, your immune system stops working and your body is no longer able to do this. Research has shown that cancer cells in some patients start to make signals that stop the body's immune system from killing the cancer. One such signal is called Programmed Cell Death Ligand 1 or PD-L1 for short. New drugs like Durvalumab work to stop this signal and to increase the immune response, and it is hoped that by stopping this signal, the immune cells will once again be able to prevent or slow down cancer growth. Durvalumab is an antibody (a protein produced by the body's defense system). A number of different tests will need to be done to test if Durvalumab works and to learn what side effects there might be. Research has shown that some cancer cells make a protein called vascular endothelial growth factor or VEGF for short. VEGF causes the formation of blood vessels to the tumors amongst other biologic roles. Research has shown that VEGF plays a role in HCC. Drugs like Bevacizumab block the VEGF signal. We don't know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for hepatocellular carcinoma in the future.
Description
TACE in Combination with Durvalumab & Bevacizumab Therapy in Locoregional HCC (EMERALD-1)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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