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

Not Applicable

Recruiting

• Conditions: Hapatocellular carcinoma

• Registration Number: JPRN-UMIN000045131
• Lead Sponsor: ational Center for Global Health and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 17 October 2023
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum cytokine, PD-L1, PD-1, CTLA-4

Secondary Outcome Measures

Name	Time	Method
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