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Trial Title:
Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
NCT ID:
NCT05575622
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection
Description:
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.
Arm group label:
Patients with hepatocellular carcinoma receiving immunotherapy
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.
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.
Criteria for eligibility:
Study pop:
All patients in this study were enrolled by the Clinical Trial Centerin Zhongnan
Hospital.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Fubing Wang, Doctor
Phone:
86-15872385253
Email:
wfb20042002@sina.com
Start date:
January 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05575622
