Exploratory biomarker study on tumor microenvironment using pre-treatment and refractory archival samples of hepatocellular carcinoma

Exploratory biomarker study on tumor microenvironment using pre-treatment and refractory archival samples of hepatocellular carcinoma - Exploratory biomarker study on tumor microenvironment by archival samples of hepatocellular carcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047701

Enrollment

Registered

2022-05-10

Start date

2022-01-06

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

Unresectable hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in clinical research approved by the Ethics Review Committee of the Graduate School of Medicine, Chiba University, who have given consent in opt-out form via an information disclosure document, who meet the following eligibility criteria, and who have secondary available archival samples (tumor/non-tumor tissue samples, blood samples). 1) Unresectable hepatocellular carcinoma 2) Receiving lenvatinib, sorafenib, or atezolizumab plus bevacizumab as first-line treatment (excluding hepatic arterial infusion or hepatic arterial chemoembolization)

Exclusion criteria

Exclusion criteria: Patients who do not meet the inclusion criteria.

Design outcomes

Primary

Measure	Time frame
Correlation between the efficacy of atezolizumab + bevacizumab combination therapy (response, early PD) and tumor microenvironment (PD-1 positive effector T cells, PD-1 positive regulatory T cells, CD36 positive regulatory T cells, angiogenesis and lymphangiogenesis) and metabolic environment (concentration of fatty acids etc.) and pre- and post-treatment changes.	—

Secondary

Measure	Time frame
Correlation between the efficacy and etiology of liver (metabolic environment), correlation between atezolizumab + bevacizumab combination therapy and the signature of oncogene expression and pre- and post-treatment changes. Relation of the efficacy of the molecularly targeted agents lenvatinib and sorafenib to the tumor microenvironment and metabolic environment and pre- and post-treatment changes. Relation between the efficacy of the molecularly targeted agents lenvatinib and sorafenib before and after treatment and the signatures of oncogene expression in the etiology of liver and changes in the metabolic environment.	—

Measure

Time frame

Correlation between the efficacy and etiology of liver (metabolic environment), correlation between atezolizumab + bevacizumab combination therapy and the signature of oncogene expression and pre- and post-treatment changes. Relation of the efficacy of the molecularly targeted agents lenvatinib and sorafenib to the tumor microenvironment and metabolic environment and pre- and post-treatment changes. Relation between the efficacy of the molecularly targeted agents lenvatinib and sorafenib before and after treatment and the signatures of oncogene expression in the etiology of liver and changes in the metabolic environment.

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Countries

Japan

Contacts

Public ContactSadahisa Ogasawara

Chiba University Hospital Department of Gastroenterology

kato.naoya@chiba-u.jp043-222-7171

Outcome results