Chemotherapy + Atezolizumab for Advanced Liver Cancer

Recruiting in Palo Alto (17 mi)

+42 other locations

Overseen byDavid Hsieh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with liver cancer that cannot be removed by surgery (unresectable) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab and atezolizumab with chemotherapy may kill more tumor cells in patients liver cancer than chemotherapy and atezolizumab.

Eligibility Criteria

Adults with advanced liver cancer that can't be surgically removed or has spread, who've completed certain treatments over 4 weeks ago. They must have adequate blood counts and organ function, not be pregnant/breastfeeding, free from autoimmune diseases or immune deficiencies (with some exceptions), and without a history of severe allergies to trial drugs.

Inclusion Criteria

My cancer cannot be removed by surgery or has spread to other parts of my body.

My hemoglobin level is at least 9 g/dL, possibly after a transfusion.

My white blood cell count is healthy for treatment.

+24 more

Exclusion Criteria

I do not have any bleeding disorders or significant blood clotting issues.

I haven't taken any immune-boosting drugs in the last 4 weeks or longer.

I have skin conditions like eczema or psoriasis without any related arthritis.

+34 more

Participant Groups

The study is testing if adding Bevacizumab (an antiangiogenic agent) to the combination of Chemotherapy (Gemcitabine and Cisplatin) and Atezolizumab (a monoclonal antibody immunotherapy) is more effective in treating unresectable or advanced liver cancer than just Chemotherapy with Atezolizumab.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (atezolizumab, bevacizumab, gemcitabine, cisplatin)Experimental Treatment7 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients undergo blood specimen collection on study.

Group II: Arm B (atezolizumab, gemcitabine, cisplatin)Active Control6 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1, and gemcitabine IV over 30 minutes and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or magnetic resonance imaging MRI throughout the trial. Patients undergo blood specimen collection on study.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: