A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HCC - Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: From treatment initiation to 12 weeks after first therapy cycle.]
Secondary outcome measures (2)
- Recurrence-Free Survival (RFS) [Time frame: From surgery date to first recurrence or death (assessed monthly for 24 months).]
- Severe Treatment-Related Side Effects [Time frame: From first treatment dose to 30 days after final dose.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07117279 · TJ-IRB202506074