A prospective observational study of Atezolizumab plus Bevacizumab in patients with unresectable hepatocellular carcinoma
Not Applicable
- Conditions
- hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000043463
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 510
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding*. *: Patients who underwent esophagogastroduodenoscopy (EGD) prior to enrollment and were judged to be at low risk of bleeding after assessment of all size of varices (small to large) can be enrolled in this study. *: Patients who have undergone EGD within 6 months of prior to initiation of Atezolizumab+Bevacizumab combination therapy do not need to perform the EGD again. (2) Patients who are judged unsuitable for enrollment into the study by the principal investigator or sub-investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of Adverse events of special interest
- Secondary Outcome Measures
Name Time Method (1) Incidence rate of irAE (immune-related Adverse Events) (2) Proportion of patients treated by steroids for irAE management (3) Changes of hepatic function (4) Time to Child-Pugh B (5) Geriatric Assessment (G8:Geriatric 8): For patients aged 65 years and older (6) Objective response rate (7) Time to treatment failure (8) Progression-free survival (9) Overall survival (10) Transition rate to subsequent treatment (11) Physical activity assessments* (12) Patient-reported outcomes (PROs)* *(11), (12): For only the investigator's site which participated in physical activity assessment program.