Unresectable hepatocellular carcinoma (HCC) MedDRA version: 21.0 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Tecentriq
Product Name: Atezolizumab
Product Code: [RO5541267]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Atezolizumab
CAS Number: 1380723-44-3
Current
Sponsors
ROCHE SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form; • Age >=18 years at time of signing Informed Consent Form; • Ability to comply with the study protocol, in the investigator's judgment; • Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months from recruitment; • Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies; • No prior systemic therapy (including systemic investigational agents) for HCC; • At least one measurable (per RECIST 1.1) untreated lesion; • Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, SIRT etc.) are 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; • ECOG Performance Status of 0 or 1 within 7 days prior to recruitment; • Child-Pugh class A within 7 days prior to recruitment; 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: • History of leptomeningeal disease or brain metastases; • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: - Rash must cover 500 ms (calculated with use of the Fridericia method) at screening; • History of uncorrectable electrolyte disorder affecting serum levels of potassium, calcium, or magnesium; • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of atezolizumab + bevacizumab in terms of bleeding/haemorrhage;Secondary Objective: - To evaluate the efficacy of atezolizumab + bevacizumab - To further evaluate the safety of atezolizumab + bevacizumab - To evaluate Patient Reported Outcomes (PROs) and to describe the patient’s experience while receiving atezolizumab + bevacizumab - To evaluate whether the patterns of tumor progression (growth versus new lesion, intrahepatic versus extrahepatic) have a different impact on OS and PPS - To evaluate if post-study treatment have impact on OS - To evaluate if reason of treatment withdrawal has impact on OS - Gut Microbiome evaluation;Primary end point(s): Incidence of Grade 3-5 NCI CTCAE v.5 bleeding/haemorrhage;Timepoint(s) of evaluation of this end point: An interim analysis of safety will be performed at the time of 50 recruited patients, estimated to occur at approximately 6 months after FPI. The primary analysis of the safety endpoints and secondary endpoints will be undertaken once all patients have completed the study treatment phase and safety follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS), defined as the time from initiation of study treatment to death from any cause - Incidence and severity of adverse events (AEs), with severity determined according to NCI CTCAE v5.0 - Vital signs - Clinical laboratory test results - Patient self-reported symptomatic Adverse Events (AEs) using National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - OS and PPS based on the following patterns of progression: - >20% increase in tumor size against a known baseline lesion (intrahepatic growth [IHG] or extrahepatic growth [EHG]) - new intrahepatic tumor lesion (NIH) >10 mm - new extrahepatic lesion (NEH) and/or vascular invasion - OS based on type and duration of each post-study treatments - OS based on the following reasons of treatment withdrawal: -Progressive disease (PD) vs AEs vs deteriorating liver function/clinical conditions - Relationship between the gut microbiome and antitumour responses following atezolizumab and bevacizumab;Timepoint(s) of evaluation of this end point: An interim analysis of safety will be performed at the time of 50 recruited patients, estimated to occur at approximately 6 months after FPI. The primary analysis of the safety endpoints and secondary endpoints will be undertaken once all patients have completed the study treatment phase and safety follow-up. | — |
Countries
Italy
Contacts
Public ContactMedical Affairs&Clinical Operations
Roche SpA
Outcome results
None listed