Hepatocellular CarcinomaNCT05575622
Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Zhongnan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in this study were enrolled by the Clinical Trial Centerin Zhongnan Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fubing Wang, Doctor, 86-15872385253, wfb20042002@sina.com
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatocellular carcinoma receiving immunotherapy | Not described Receives: Device: CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC-PD-L1, exosomal PD-L1, and exosomal LAG-3
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fubing Wang, Doctor, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575622
- Sponsor's protocol ID
- 20221002
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05575622
- Acronym / sponsor ID
- 20221002
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatocellular carcinoma receiving immunotherapy | – | Device: CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in this study were enrolled by the Clinical Trial Centerin Zhongnan Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detectionCollect 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. | Device | Patients with hepatocellular carcinoma receiving immunotherapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fubing Wang, Doctor study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fubing Wang, Doctor (86-15872385253, wfb20042002@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.