- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575622
Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
October 20, 2022 updated by: Zhongnan Hospital
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fubing Wang, Doctor
- Phone Number: 86-15872385253
- Email: wfb20042002@sina.com
Study Contact Backup
- Name: Ying Zhang, Doctor
- Phone Number: 86-18946728919
- Email: 2022183030053@whu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430071
- Recruiting
- Zhongnan Hospital of Wuhan University
-
Contact:
- Fubing Wang, Doctor
- Phone Number: 86-15872385253
- Email: wfb20042002@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients in this study were enrolled by the Clinical Trial Centerin Zhongnan Hospital.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with hepatocellular carcinoma receiving immunotherapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CTC-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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fubing Wang, Doctor, Wuhan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
October 3, 2022
First Submitted That Met QC Criteria
October 10, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Actual)
October 24, 2022
Last Update Submitted That Met QC Criteria
October 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20221002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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