Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.

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Detailed Description

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Liquid biopsy methods such as PD-L1 of CTC, number of peripheral immune cells and their subtypes, and exosomal PD-L1 provide a dynamic monitoring strategy for immunotherapy evaluation. Monitoring CTC and immune-related functional markers in peripheral blood can dynamically reflect the multi-dimensional characteristics of tumor microenvironment, comprehensively represent the response of patients to immunotherapy, and provide a new strategy of companion diagnostics for immunotherapy in HCC. This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hepatocellular carcinoma receiving immunotherapy

CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection

Intervention Type DEVICE

Collect peripheral blood sample of 200 HCC patients at treatment baseline, every time point response till disease progression.Blood samples will be transferred to central lab to detect CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 by microfluidic chip.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastatic organ ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Interventions

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CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection

Collect peripheral blood sample of 200 HCC patients at treatment baseline, every time point response till disease progression.Blood samples will be transferred to central lab to detect CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 by microfluidic chip.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastatic organ ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* having signed informed consent
* clinically or pathologically confirmed hepatocellular carcinoma;
* liver tumor load not exceeding 50% of liver volume;
* expected survival ≥ 12 weeks;
* vital organ function meeting enrollment criteria; and (6) no need for pregnancy.

Exclusion Criteria

* Patients who have been diagnosed with malignant tumors of other systems or organs;
* Patients with hematologic disorders and extreme physical failure;
* Patients with immune deficiencies or organ transplants;
* Other conditions deemed by the investigator to be inappropriate for participation in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No