TACE + Durvalumab + Bevacizumab for Liver Cancer

(EMERALD-1 Trial)

Recruiting in Palo Alto (17 mi)

+155 other locations

Overseen by Riccardo Lencioni, MD FSIR EBIR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

Research Team

Bruno Sangro, MD

Principal Investigator

Clinica Universidad de Navarra

Riccardo Lencioni, MD FSIR EBIR

Principal Investigator

University of Pisa / Miami Cancer Institute

Eligibility Criteria

This trial is for adults with hepatocellular carcinoma (a type of liver cancer) that hasn't spread outside the liver and can't be treated with surgery or transplantation. Participants should have a certain level of liver function (Child-Pugh score class A to B7), an ECOG performance status of 0 or 1, and no recent significant cardiovascular issues, GI perforations, bleeding disorders, or major surgeries.

Inclusion Criteria

My organs and bone marrow are working well.

My condition cannot be cured with surgery or transplantation, but can be treated with TACE.

Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria

Exclusion Criteria

I have a history of kidney disorders.

Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded

I haven't had surgery in the last 28 days and don't have bleeding disorders.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Durvalumab (Monoclonal Antibodies)
• Transarterial Chemoembolization (TACE) (Procedure)

Trial Overview The study tests if combining TACE—a procedure blocking blood flow to parts of the liver—with Durvalumab and Bevacizumab drugs improves outcomes in patients with localized liver cancer. Some participants will receive a placebo instead of these drugs as part of the study's comparison.

Participant Groups

Group I: Arm B Experimental Treatment 3 Interventions

Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab

Group II: Arm A Experimental Treatment 3 Interventions

Transarterial Chemoembolization (TACE) in combination with Durvalumab

Group III: Arm C Placebo Group 2 Interventions

Transarterial Chemoembolization (TACE) in combination with Placebos

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology