A prospective observational study of Atezolizumab plus Bevacizumab in patients with unresectable hepatocellular carcinoma

A prospective observational study of Atezolizumab plus Bevacizumab in patients with unresectable hepatocellular carcinoma - ELIXIR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043463

Enrollment

500

Registered

2021-03-01

Start date

2021-03-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age >= 20 years at time of signing informed consent form (2) Unresectable hepatocellular carcinoma (3) Child-Pugh Score class A (4) No prior systemic therapy for unresectable hepatocellular carcinoma *: Patients who have relapsed more than 6 months after the end of postoperative adjuvant therapy can be enrolled. (5) Patients who are scheduled to start atezolizumab plus bevacizumab combination therapy in clinical practice according to the atezolizumab and bevacizumab package inserts and the Optimal Use Practice Guideline. (6) Patients who have received sufficient explanation about the content of this study and have signed a consent form of their own free will

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Incidence rate of Adverse events of special interest	—

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

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Countries

Japan

Contacts

Public ContactHiroshi Morifuji

A2 Healthcare Corporation Clinical Planning Division

elixir-jimu@a2healthcare.com03-3830-1158

Outcome results