NCT05211323

A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer

A Randomized Phase II Trial Evaluating Chemotherapy Plus Atezolizumab vs Chemotherapy Plus Bevacizumab and Atezolizumab in Advanced Combined Hepatocellular Carcinoma-Cholangiocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate whether a quadruplet combined chemotherapy, immunotherapy, and anti-VEGF therapy improves progression-free survival (PFS), defined as time to progressive disease or death due to any cause as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, compared to chemotherapy plus immunotherapy in patients with advanced combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC). SECONDARY OBJECTIVES: I. To evaluate whether a quadruplet combined chemotherapy, immunotherapy, and anti-VEGF therapy improves objective response (OR), defined as a complete or partial response as determined by the investigator according to RECIST v1.1, compared to chemotherapy plus immunotherapy in patients with advanced cHCC-CC. II. To evaluate whether a quadruplet combined chemotherapy, immunotherapy, and anti-VEGF therapy improves overall response (OS), and disease control rate as determined by the investigator using RECIST v1.1, compared to chemotherapy plus immunotherapy in patients with advanced cHCC-CC. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive atezolizumab intravenously (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 computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. Patients undergo blood specimen collection on study. ARM B: 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. After completion of study treatment, patients are followed up for 3 years.

Conditions

• Combined Hepatocellular Carcinoma and Cholangiocarcinoma
• Stage III Liver Cancer
• Stage IV Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
BIOLOGICAL	Bevacizumab	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood specimen collection
DRUG	Cisplatin	Given IV
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Conventional Magnetic Resonance Imaging	Undergo MRI
DRUG	Gemcitabine Hydrochloride	Given IV

Timeline

• Start date: 2022-12-07
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-01-27
• Last updated: 2026-04-13

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study