Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with hepatocellular carcinoma receiving immunotherapy
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Device: 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.
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Outcome Measures
Primary Outcome Measures
- CTC-PD-L1, exosomal PD-L1, and exosomal LAG-3 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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having signed informed consent
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clinically or pathologically confirmed hepatocellular carcinoma;
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liver tumor load not exceeding 50% of liver volume;
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expected survival ≥ 12 weeks;
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vital organ function meeting enrollment criteria; and (6) no need for pregnancy.
Exclusion Criteria:
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Patients who have been diagnosed with malignant tumors of other systems or organs;
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Patients with hematologic disorders and extreme physical failure;
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Patients with immune deficiencies or organ transplants;
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Other conditions deemed by the investigator to be inappropriate for participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China | 430071 |
Sponsors and Collaborators
- Zhongnan Hospital
Investigators
- Study Director: Fubing Wang, Doctor, Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20221002