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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGCTC-PD-L1, exosomal PD-L1, and exosomal LAG-3
Time frame: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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