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

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection

• Registration Number: NCT05575622
• Lead Sponsor: Zhongnan Hospital

Brief 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-12
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Study Start: 2023-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hepatocellular carcinoma receiving immunotherapy	CTC PD-L1, exosomal PD-L1, and exosomal LAG-3 detection	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China