What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as Atezolizumab (PD-L1 inhibition), Bevacizumab (VEGF inhibition), and Transarterial Chemoembolization (TACE), have specific side effects. Atezolizumab can cause immune-related adverse events like fatigue, rash, diarrhea, and liver enzyme abnormalities. Bevacizumab is associated with hypertension, proteinuria, bleeding, and gastrointestinal perforation. TACE can lead to post-embolization syndrome, which includes pain, fever, and nausea, as well as liver dysfunction and, in rare cases, liver abscess or bile duct injury.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, particularly focusing on advanced hepatocellular carcinoma (HCC). Sorafenib, a multitargeted tyrosine kinase inhibitor, was one of the first systemic therapies approved for unresectable HCC. More recently, the combination of atezolizumab (a PD-L1 inhibitor) and bevacizumab (a VEGF inhibitor) has shown significant survival benefits over sorafenib, leading to its approval for advanced HCC. This combination leverages immune checkpoint inhibition and anti-angiogenesis to enhance treatment efficacy. Additionally, local tumor ablation techniques like Transarterial Chemoembolization (TACE) are often used in combination with systemic therapies to improve outcomes by increasing tumor immunogenicity.

What other types of research exist?

Promising alternatives to atezolizumab and bevacizumab with TACE for liver cancer patients include: 1) Lenvatinib plus TACE, which has shown potential in the phase III LAUNCH trial, particularly for patients with a large intrahepatic tumor burden. 2) Hepatic arterial infusion chemotherapy (HAIC) with or without sorafenib, which is an option where local expertise is available. 3) External beam radiotherapy (EBRT), including stereotactic body radiotherapy (SBRT), for patients who are ineligible for transplantation and other liver-directed therapies.

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Monoclonal Antibodies

Atezolizumab + Bevacizumab + TACE for Liver Cancer

Phase 2

Recruiting

Led By Stacy Stein, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a combination of two drugs and a targeted procedure to treat liver cancer in patients with limited treatment options. The treatment boosts the immune system, starves the tumor of nutrients, and delivers targeted chemotherapy.

Who is the study for?

This trial is for adults with intermediate-stage liver cancer (BCLC B HCC) who can handle the study procedures and have a life expectancy of at least 6 months. They should not have severe cirrhosis, must be eligible for TACE therapy, and need to have good liver, bone marrow, and kidney function. People with certain hepatitis conditions can join if they meet specific criteria.

What is being tested?

The trial tests Atezolizumab and Bevacizumab in combination with Transarterial Chemoembolization (TACE). It aims to see if this combo helps patients by increasing the immune system's response to cancer after local tumor treatment.

What are the potential side effects?

Atezolizumab may cause immune-related reactions or infections; Bevacizumab might lead to high blood pressure or bleeding issues; TACE could result in abdominal pain or fever. Each patient's side effects will vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grade 3 or higher Treatment Related Adverse Events

Secondary study objectives

Response rate in Hepatocellular Carcinoma

Response rate in Solid Tumors

Time to TACE progression (TTTP)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Atezolizumab and Bevacizumab in combination with TACEExperimental Treatment3 Interventions

THIS IS A SINGLE ARM PILOT/FEASABILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT. The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule. Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Transarterial chemoembolization

2019

Completed Phase 3

~1230

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atezolizumab, an immune checkpoint inhibitor, targets PD-L1 to enhance the immune system's ability to recognize and destroy liver cancer cells. Bevacizumab, an anti-VEGF antibody, inhibits angiogenesis, reducing the tumor's blood supply and limiting its growth. Transarterial Chemoembolization (TACE) delivers chemotherapy directly to the liver tumor while blocking its blood supply, causing tumor cell death. These treatments are significant for liver cancer patients as they provide a comprehensive approach to target the tumor both locally and systemically, potentially improving treatment efficacy and patient outcomes.

Targeted therapy for liver cancer: updated review in 2012.