Clinical trial · Observational
A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC - Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From treatment initiation to 12 weeks after first therapy cycle.
- description
- 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 (2)
- measure
- Recurrence-Free Survival (RFS)
- timeFrame
- From surgery date to first recurrence or death (assessed monthly for 24 months).
- description
- 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.
- measure
- Severe Treatment-Related Side Effects
- timeFrame
- From first treatment dose to 30 days after final dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available