What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as atezolizumab (an immune checkpoint inhibitor) and bevacizumab (an anti-angiogenic), have distinct side effect profiles. Atezolizumab can cause immune-related adverse events, including autoimmune retinopathy, uveitis, and other autoimmune diseases. Bevacizumab is associated with hypertension, thrombotic events, and wound healing issues. When combined, these treatments can lead to a range of side effects, encompassing both immune system activation and vascular complications.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including sorafenib and lenvatinib, which are tyrosine kinase inhibitors targeting multiple pathways including angiogenesis. More recently, the combination of atezolizumab, an immune checkpoint inhibitor, and bevacizumab, an anti-angiogenic agent, has been approved for the treatment of unresectable hepatocellular carcinoma. This combination leverages the immune-modulating effects of atezolizumab and the anti-angiogenic properties of bevacizumab to improve patient outcomes.

What other types of research exist?

Promising alternatives to atezolizumab and bevacizumab for liver cancer patients include: 1) Tremelimumab plus Durvalumab, which has shown efficacy in unresectable hepatocellular carcinoma. 2) Lenvatinib combined with transarterial chemoembolization (TACE), which is being evaluated as a first-line treatment for advanced hepatocellular carcinoma. 3) Sorafenib, which has been a standard treatment and is still relevant in various combinations and specific patient subsets.

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Monoclonal Antibodies

Immunotherapy + Antiviral Therapy for Liver Cancer and Hepatitis C

Phase 4

Waitlist Available

Led By Harrys A. Torres, MD

Research Sponsored by M.D. Anderson Cancer Center

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 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses a combination of cancer-fighting drugs and hepatitis C treatments. It targets patients with liver cancer and chronic hepatitis C. The treatment aims to boost the immune system to fight cancer and clear the hepatitis C virus. The combination therapy of interferon and ribavirin has been used to treat chronic hepatitis C, showing potential for remission or cure.

Who is the study for?

Adults with advanced liver cancer (HCC) and chronic Hepatitis C who haven't had systemic therapy for HCC, have a life expectancy over 3 months, and can't be cured by surgery or local therapies. They must have detectable Hepatitis C virus RNA, acceptable organ function, no history of certain other diseases or conditions that could interfere with the trial, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The study is testing if combining immune checkpoint therapy (atezolizumab) with bevacizumab alongside direct-acting antiviral drugs improves control of liver cancer and Hepatitis C in patients. It's seeing if this approach works better than current treatments.

What are the potential side effects?

Possible side effects include high blood pressure from bevacizumab; fatigue, nausea from atezolizumab; headache and tiredness from sofosbuvir/velpatasvir/voxilaprevir; anemia from ribavirin. Side effects vary per person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DAA therapy plus Bevacizumb and AtezolizumabExperimental Treatment6 Interventions

Participants will receive bevacizumab and atezolizumab about every 3 weeks as part of the standard of care HCC treatment that is managed by your cancer doctor. In addition, Participants will continue receiving your standard of care DAAs (either sofosbuvir + velpatasvir or sofosbuvir + velpatasvir + voxilaprevir)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Atezolizumab

2016

Completed Phase 3

~5860

Sofosbuvir

2014

Completed Phase 4

~2640

Velpatasvir

2014

Completed Phase 1

~1250

Voxilaprevir

2014

Completed Phase 1

~160

Ribavirin

2010

Completed Phase 3

~3250

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, works by blocking the PD-L1 protein, which helps cancer cells evade the immune system, thereby enabling the immune system to target and destroy cancer cells. Bevacizumab, an anti-angiogenic agent, inhibits vascular endothelial growth factor (VEGF), essential for new blood vessel formation that tumors require for growth. For liver cancer patients, combining these treatments can enhance the immune response against cancer cells while simultaneously disrupting the tumor's blood supply, potentially leading to improved disease control and outcomes.

Targeting vascular endothelial growth factor with the monoclonal antibody bevacizumab inhibits human hepatocellular carcinoma cells growing in an orthotopic mouse model.