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
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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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-09-01
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Main portal vein tumor thrombosis (VP4)
* Active autoimmune disease requiring immunosuppression
* HIV/HBV/HCV with uncontrolled viral replication
* Pregnancy or refusal of contraception
18 Years
75 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Zhang Bi Xiang, MD
Professor
Other Identifiers
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TJ-IRB202506074
Identifier Type: -
Identifier Source: org_study_id
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