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

Zhongnan Hospital

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Device: CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection

Study type: Observational

Funder types: Other

Identifiers

NCT05575622

20221002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Patients with hepatocellular carcinoma receiving immunotherapy

Treatment:

Device: CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection