Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575622
• Other study ID #: 20221002
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Zhongnan Hospital
• Contact: Fubing Wang, Doctor
• Phone: 86-15872385253
• Email: wfb20042002[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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