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

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Objective Response Rate (ORR)

Time frame: 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 outcomes

Recurrence-Free Survival (RFS)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Aug 12, 2025
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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