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

Running, not enrolling · Phase 2

Conditions studied: Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Stage III Liver Cancer, Stage IV Liver Cancer

In brief

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.

Key facts

Study ID

NCT05211323

Run by

National Cancer Institute (NCI)

People needed

88

Starts

2022-12-07

Expected to finish

2026-09-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be >= 18 years of age
• Patient must have a histologically confirmed diagnosis of combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CC) at the local laboratory based on the 2019 World Health Organization (WHO) classification, including the classical type and intermediate cell carcinoma
• The classical type defines primary liver carcinoma with unequivocal features of both HCC and CC differentiation within the same tumors on routine histopathology with hematoxylin and eosin stains regardless of the proportion of each histology observed
• The intermediate cell carcinoma defines cancers with biphenotypic differentiation in which cells have a morphology intermediate between hepatocytes and cholangiocytes. Intermediate cell carcinoma may be associated with expression of both hepatocyte and cholangiocytic markers. Distinct HCC and CC arising in the same liver, fibrolamellar HCC, morphologically typical HCCs with only immunohistochemical expression of keratin or other cholangiocytic markers, or morphologically typical CCs with only immunohistochemical expression of hepatocytic markers will be excluded
• NOTE: Local pathology review constitutes adequate documentation of histology for initial study enrollment and treatment
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patient must have disease which is unresectable or metastatic
• Patient must not have any prior history of systemic therapy for advanced cHCC-CC. Prior adjuvant treatment composed of chemotherapy agents such as capecitabine or gemcitabine-based treatments are allowed if adjuvant treatment if at least 6 months have elapsed since completing chemotherapy at the time of enrollment
• Patient must be Child Pugh class A
• Patients with prior locoregional therapy are eligible provided the following are met:
• Prior loco-regional therapy including surgical resection, chemoembolization, radiotherapy, or ablation was completed > 4 weeks prior to randomization
• Treated target lesion has increased in size by > 25% or the target lesion was not treated with loco-regional therapy
• Patients treated with palliative radiotherapy for symptoms must have completed radiotherapy > 7 days prior to randomization and the target lesion must not have been the treated lesion
• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
• All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
• A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patient must not expect to conceive or father children by abstaining from sexual intercourse or by using accepted and effective method(s) of contraception while on protocol treatment and for 6 months after the last dose of protocol treatment. Accepted and effective method(s) of contraception include those with a failure rate of < 1% per year including bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovluation, hormonal releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception
• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
• Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol randomization)
• Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol randomization)
• Hemoglobin >= 9 g/dL (Patient may be transfused to meet this criterion) (must be obtained =< 14 days prior to protocol randomization)
• Platelets >= 80,000/mcL (must be obtained =< 14 days prior to protocol randomization)
• Total bilirubin =< 5 x institutional upper limit of normal (ULN) (must be obtained =< 14 days prior to protocol randomization)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 x institutional ULN (must be obtained =< 14 days prior to protocol randomization)
• Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol randomization)

Where it is running

• Sutter Auburn Faith Hospital — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States
• Memorial Medical Center — Modesto, California, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Palo Alto Medical Foundation-Santa Cruz — Santa Cruz, California, United States
• Palo Alto Medical Foundation-Sunnyvale — Sunnyvale, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• Carle at The Riverfront — Danville, Illinois, United States
• Carle Physician Group-Effingham — Effingham, Illinois, United States
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• The Carle Foundation Hospital — Urbana, Illinois, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Miami Valley Hospital South — Centerville, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• Premier Blood and Cancer Center — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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