Atezolizumab + Bevacizumab + TACE for Liver Cancer

Overseen By Maxime Oriol

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Aspirin, Clopidogrel, others

Disqualifiers: Liver failure, Hypertension, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 18 months

3 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stacy Stein, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

I have Hepatitis B but my viral load is undetectable and I don't need HBV antiviral prophylaxis.

Alanine Transaminase (ALT) < 5X ULN

My liver is healthy or has mild cirrhosis.

Exclusion Criteria

I have not taken any antibiotics by mouth or IV in the last 2 weeks.

I have had confusion due to liver problems in the last year.

I have had treatments for liver cancer but not RFA.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive atezolizumab and bevacizumab every 21 days, followed by TACE treatment 4 to 5 weeks after study drugs

18 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atezolizumab Injection
• Bevacizumab
• Transarterial chemoembolization

Trial Overview 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.

Participant Groups

Group I: Atezolizumab and Bevacizumab in combination with TACE Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD