Treatment for patients with unresectable HCC who have received no prior systemic treatment and are considered unsuitable for locoregional therapy.
Conditions
Sponsors
Roche Farma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed ICF, Age = 18 years, Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically. - Not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies. - No prior systemic therapy for HCC - One measurable (per RECIST 1.1) untreated lesion detected by CT scan. - 3 months to be included for those patients who received external beam radiotherapy as prior locoregional therapy. - ECOG Performance Status of 0 or 1 within 7 days prior to recruitment - Pre-treatment tumor tissue or a new tumor sample with specimen associated pathology report. - Patients with prior local therapy eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1: -Adequate hematologic and end-organ function, obtained within 7 days prior to recruitment. - Resolution of any acute, toxicity from prior therapy to Grade = 1 prior to study entry. - Negative HIV test at screening. Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test - For women of childbearing potential: agreement to remain abstinent Women must refrain from donating eggs during this same period. - For men: agreement to remain abstinent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from entry: - Active or history of autoimmune disease or immune deficiency EXCEPT Patients with a history of autoimmune-related hypothyroidism , with controlled Type 1 diabetes mellitus and with eczema, psoriasis, lichen simplex chronicus, or vitiligo. - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest (CT) scan. - Significant cardiovascular disease. - History of congenital long QT syndrome or corrected QT interval >500 ms at screening. - History of uncorrectable electrolyte disorder. - Major surgical procedure, other than for diagnosis. - History of malignancy other than HCC within 5 years prior to screening - Severe infection within 4 weeks prior to initiation of study treatment - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment - Prior allogeneic stem cell or solid organ transplantation - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding -Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, -Pregnancy or breastfeeding, or intention of becoming pregnant. - Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding. - At least one clinically evident episode of encephalopathy in the past three months . - Co-infection of HBV and HCV. -Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. - Uncontrolled tumor-related pain. -Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures . - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment - If a diagnosis of COVID-19 infection is confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to evaluate the safety of atezolizumab in combination with bevacizumab in patients with unresectable HCC who have received no prior systemic treatment and are considered unsuitable for locoregional therapy.;Secondary Objective: - To evaluate the efficacy of atezolizumab + bevacizumab. OS, defined as the time from initiation of study treatment to death from any cause. - To further evaluate the safety of atezolizumab + bevacizumab. -Adverse Event severity according to NCI CTCAE v5.0 during patient’s treatment. - To further evaluate the efficacy of atezolizumab + bevacizumab, According to RECIST 1.1: *PFS. * Objective response rate (ORR), defined as a complete or partial response, on two consecutive occasions = 4 weeks apart. * Time to progression (TTP), defined as the time from initiation of study treatment to the first occurrence of disease progression. * Duration of Response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) * Number/Rate of patients starting second line treatment. - To evaluate deterioration of Liver function during the treatment;Primary end point(s): The primary endpoint is the incidence and severity of adverse events of grade = 3 that lead to discontinuation of study treatment.;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - secondary endpoints of severity of AEs (determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE v5.0]), as well as changes from baseline in targeted vital signs and clinical laboratory test results will be evaluated during the patients’ treatment. - overall survival ([OS] defined as the time from initiation of study treatment to death from any cause;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Spain
Contacts
Public ContactHead of Spain
Roche Farma S.A.
Outcome results
None listed