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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining two drugs, atezolizumab (an injection) and bevacizumab (also known as Avastin), with Transarterial Chemoembolization (TACE) for individuals with intermediate-stage liver cancer (hepatocellular carcinoma, HCC). Researchers believe this combination might enhance the immune system's response to cancer, potentially improving patient outcomes at this stage. It suits those diagnosed with intermediate-stage HCC who qualify for TACE treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like high-dose aspirin and specific anticoagulants are restricted, and you should discuss your current medications with the trial team to ensure they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using atezolizumab, bevacizumab, and TACE (a type of targeted chemotherapy) together is generally safe for people with liver cancer. Studies have found that this combination has manageable side effects, particularly for liver cancer that cannot be surgically removed. One study found that this treatment helped patients live longer and delayed cancer progression.

The treatment's safety appears acceptable, with manageable side effects. Another study found that using TACE with atezolizumab and bevacizumab is safe for people with intermediate-stage liver cancer, suggesting the combination is well-tolerated and merits further research.

These findings indicate the treatment is safe, but discussing personal risks and benefits with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining atezolizumab and bevacizumab with TACE for liver cancer because this approach brings together immunotherapy and targeted therapy in a potentially powerful way. Atezolizumab works by boosting the immune system to better fight cancer cells, while bevacizumab inhibits blood vessel growth that tumors rely on. This dual-action approach may offer more comprehensive treatment compared to standard therapies, which typically target one aspect of the cancer. Additionally, the inclusion of TACE, a procedure that delivers chemotherapy directly to the liver, provides a localized treatment boost, potentially enhancing the overall effectiveness against liver tumors.

What evidence suggests that the combination of atezolizumab, bevacizumab, and TACE could be effective for liver cancer?

Research has shown that combining the drugs atezolizumab and bevacizumab with Transarterial Chemoembolization (TACE) shows promise for treating intermediate hepatocellular carcinoma (HCC), a type of liver cancer. This trial will evaluate the effectiveness of this combination, as studies have found that it helps patients live longer and slows cancer growth. Most patients can generally manage the side effects. Adding TACE to treatment with atezolizumab and bevacizumab appears to enhance effectiveness. Overall, this treatment offers hope for patients with this type of liver cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Stacy Stein, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11505562/

Efficacy of Atezolizumab Plus Bevacizumab Combined with ... The combination of Atezo/Bev with TACE demonstrated acceptable synergistic therapeutic effects and manageable safety profiles in patients with unresectable HCC.

2. nature.com nature.com/articles/s41392-025-02427-0

Transarterial chemoembolization plus atezolizumab and ... Transarterial chemoembolization plus atezolizumab and bevacizumab in patients with intermediate hepatocellular carcinoma: a single-arm, phase 2 ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4105

Efficacy and safety of atezolizumab and bevacizumab with ... TACE-Ate-Bev significantly improves OS and PFS with acceptable toxicity compared to Ate-Bev as first-line therapy for advanced HCC.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04803994

NCT04803994 | The ABC-HCC Trial: Atezolizumab Plus ... The main purpose of this phase IIIb study is to test the efficacy and safety of atezolizumab in combination with bevacizumab compared to TACE in patients with ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11389-x

Improved clinical outcomes in advanced hepatocellular ... Compared with Atez/Bev treatment, TACE-Atez/Bev showed better OS, PFS, and ORR for Chinese patients with advanced HCC, with an acceptable safety profile.

6. sciencedirect.com sciencedirect.com/science/article/pii/S166526812500331X

A study on the safety and effectiveness of transcatheter ... To evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with intra-arterial bevacizumab infusion in ...