None listed
Conditions
Interventions
Drug : Atezolizumab is administered as a fixed dose of 1,200 mg via intravenous infusion on Day 1 of each 21-day cycle. The initial dose of atezolizumab is administered over approximately 60 minutes.
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects with a histologically, cytologically, or radiologically confirmed diagnosis of locally advanced, metastatic, and/or unresectable hepatocellular carcinoma (2) Subjects aged =19 years at the time of signing the informed consent form (3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose (4) Child-Pugh class A (score 5–6) within 7 days prior to the first dose (5) Disease not amenable to curative surgical and/or locoregional therapy - Patients who have experienced disease progression after surgical and/or locoregional therapy are eligible (6) Subjects who provide written informed consent prior to initiation of any study procedures, demonstrating clear and voluntary agreement, including compliance with the requirements and restrictions described in the informed consent form (ICF) and this clinical trial protocol (7) Subjects who have not received prior systemic therapy (including investigational agents) for hepatocellular carcinoma - Prior treatment with herbal therapies, including traditional herbal medicine reported or known to have anti-cancer activity, is permitted only if such treatments are discontinued prior to initiation of study drug administration (8) Subjects with a life expectancy of at least 3 months (9) Subjects with measurable disease per RECIST version 1.1 (at least one target lesion) - Patients who have received prior locoregional therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, etc.) are eligible if the target lesion has not been previously treated with locoregional therapy or if the target lesion within the previously treated area has progressed according to RECIST version 1.1 (10) Subjects with adequate hematologic and organ function as defined by the following laboratory test results obtained within 7 days prior to the first dose (patients must not have received blood transfusion or albumin administration during screening or within 2 weeks prior to screening to meet these criteria): - ANC = 1.5 × 10?/L (=1500/µL) without granulocyte colony-stimulating factor support - Lymphocyte count = 0.5 × 10?/L (=500/µL) - Platelet count = 75 × 10?/L (=100,000/µL) - Hemoglobin = 90 g/L (=9.0 g/dL) - AST, ALT, and ALP = 5 × upper limit of normal (ULN) - Bilirubin = 3 × ULN - Creatinine = 1.5 × ULN or creatinine clearance = 50 mL/min (calculated by the Cockcroft-Gault formula) - Albumin = 28 g/L (=2.8 g/dL) - For patients not receiving anticoagulants: INR or aPTT = 1.5 × ULN; patients receiving low-molecular-weight heparin are eligible (11) Documented hepatitis virus status confirmed by screening tests for HBV and HCV - For subjects with active HBV: HBV DNA <500 IU/mL during screening, initiation of antiviral therapy at least 14 days prior to first dose, and willingness to continue antiviral therapy throughout the study - For subjects with active or prior HCV infection: confirmed negative viral load by HCV PCR - Subjects co-infected with HBV and HCV are not eligible (12) Reproductive status - Female subjects are eligible if they are not breastfeeding or pregnant - Negative serum pregnancy test within 3 days (72 hours) prior to first dose - Female subjects agree not to breastfeed from the time of consent until at least 6 months after the last dose of study drug - Women of childbearing potential and non-sterilized men agre
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of receiving systemic anticancer therapy, biological therapy, immunotherapy, hormonal therapy, or treatment in a clinical trial for locally advanced, metastatic, and/or unresectable hepatocellular carcinoma - However, prior adjuvant therapy is permitted if disease recurrence occurred at least 6 months after completion of the last adjuvant chemotherapy and/or radiotherapy (2) Subjects with multiple primary malignancies - Except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or other cancers that have not recurred for at least 5 years (3) Subjects with known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma (4) Subjects with untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding - Subjects must undergo esophagogastroduodenoscopy (EGD) to assess all varices and receive treatment according to institutional standard of care prior to enrollment. If evaluation has been performed within 6 months prior to study drug administration, the procedure does not need to be repeated (5) Subjects with residual toxicities from prior therapies that, in the opinion of the investigator, may interfere with safety evaluation of the investigational product, or subjects in whom the possibility of surgical treatment cannot be completely excluded at the time of study participation (6) Subjects with a history of severe hypersensitivity reactions to other antibody products - Subjects with current or prior use of, or hypersensitivity to, anti–PD-1, anti–PD-L1, anti–PD-L2, anti-CD137 antibodies, or other antibodies targeting T-cell regulation - Subjects with a history of allergy or hypersensitivity to atezolizumab, bevacizumab, or tocilizumab (7) Subjects with active autoimmune disease, a history of chronic or recurrent autoimmune disease, or use of immunosuppressive agents within 2 weeks prior to screening - Subjects with hypothyroidism requiring only hormone replacement therapy, vitiligo, psoriasis not requiring treatment, or other conditions considered safe by the investigator may participate - Subjects with a history of primary or secondary immunodeficiency, or current active immunodeficiency (8) Subjects with a current or prior history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings - Subjects with radiation pneumonitis may be enrolled if it is stable (beyond the acute phase) without concern for recurrence (9) Subjects with known central nervous system (CNS) metastases (10) Subjects with pericardial effusion, pleural effusion, or ascites requiring treatment (11) Subjects with uncontrolled tumor-related pain - Subjects requiring chronic use of NSAIDs during study treatment are excluded (12) Subjects who experienced transient ischemic attack or cerebrovascular accident within 180 days prior to enrollment (13) Subjects with a history of significant cardiovascular disease meeting any of the following criteria: - Myocardial infarction within 180 days prior to enrollment - Uncontrolled angina within 180 days prior to enrollment - Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV - Uncontrolled hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg persisting for more than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3 or higher immune-related adverse events (irAEs) occurring within 24 weeks of treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR;Progression free survival, PFS;Overall survival, OS;Rate of treatment discontinuation due to adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Ri Jeong
Bundang CHA General Hospital
Outcome results
None listed