Comprehensive analysis of cytokines and PD-L1 before and after administration of Atezolizumab and Bevasizumab in patients with HCC

Comprehensive analysis of cytokines and PD-L1 before and after administration of Atezolizumab and Bevasizumab in patients with HCC - ASTRAL-HCC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045131

Enrollment

Registered

2021-09-01

Start date

2021-08-01

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

Hapatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Over age 20 (2) Unresectable hepatocellular carcinoma (3) Child-Pugh class A (4) Current or prior use of sorafenib or lenvatinib (5) No implementation of transarterial chemoembolization within 60 days (6) Satisfied Indication of the package insert according of ATZ/BV (7) Approved informed consent

Exclusion criteria

Exclusion criteria: (1) Current use of anticoagulants or antiplatelets or prior use within 10 days (2) High risk of bleeding or untreated/incompletely treated esophageal/gastric varix (3) Thrombosis or embolism within 180 days (4) Major surgery within 28 days (5) Use of immunostimulants within 180 days (6) Use of immunosuppressants within 14 days (7) Autoimmune disease within 180 days (8) Double cancer or prior malignant neoplasm except early malignancy (9) Enrollment to an intervention study or a study using unapproved drug (10) Severe cardiovascular disease, unstable arrhythmia, unstable angina within 90 days (11) Pregnancy, breastfeeding, no approve for contraception (12) Uncontrollable pleural effusion, pericardial fluid, or ascites (13) Hepatic encephalopathy (14) Uncontrollable hypertension, severe infection, hemodialysis (15) Allergy or anaphylactic reaction to chimeric antibody, humanized antibody, or fusion protein (16) Allergy to atezolizumab and bevasizumab (17) Current or prior active hemorrhagic disease (18) Oral feeding difficulty (19) HIV positivity (20) Active pulmonary fibrosis or interstitial pneumonia (21) Blood transfusion or G-CSF within 14 days (22) Unsuitable patient at a physician's decision

Design outcomes

Primary

Measure	Time frame
Serum cytokine, PD-L1, PD-1, CTLA-4	—

Secondary

Measure	Time frame
Overall Response Rat, Time to treatment failure, Progression-free survival, Overall survival, Adverse event, immune-related Adverse Events (irAE), Steroid use for irAE management, Liver functional	—

Countries

Japan

Contacts

Public ContactKyoji Ito

National Center for Global Health and Medicine Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

kyito@hosp.ncgm.go.jp03-3202-7181

Outcome results