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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07117279

Enrollment

120

Registered

2025-08-12

Start date

2025-09-01

Completion date

2028-08-31

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC - Hepatocellular Carcinoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate (ORR)	From treatment initiation to 12 weeks after first therapy cycle.	Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.

Secondary

Measure	Time frame	Description
Recurrence-Free Survival (RFS)	From surgery date to first recurrence or death (assessed monthly for 24 months).	Time from successful tumor removal surgery to either: (a) new tumor growth on scans, or (b) death from any cause. Verified by quarterly CT/MRI + AFP testing.
Severe Treatment-Related Side Effects	From first treatment dose to 30 days after final dose.	Number of patients experiencing grade ≥3 adverse events (e.g., liver damage, low blood counts) confirmed by lab tests and physician evaluation, using CTCAE v5.0 grading.

Outcome results