A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma

NCT ID: NCT07117279

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-08-31

Brief Summary

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This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to:

Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.

Detailed Description

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Conditions

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HCC - Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults (18-75 years) with histologically confirmed HCC
* At least one measurable lesion ≥10 mm
* Planned HAIC/TACE + immunotherapy regimen
* Child-Pugh class A liver function
* ECOG 0-1
* Signed informed consent

Exclusion Criteria

* Prior systemic HCC therapy within 6 months
* Main portal vein tumor thrombosis (VP4)
* Active autoimmune disease requiring immunosuppression
* HIV/HBV/HCV with uncontrolled viral replication
* Pregnancy or refusal of contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Bi Xiang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TJ-IRB202506074

Identifier Type: -

Identifier Source: org_study_id

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