A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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.
次要结局
- Recurrence-Free Survival (RFS)(From surgery date to first recurrence or death (assessed monthly for 24 months).)
- Severe Treatment-Related Side Effects(From first treatment dose to 30 days after final dose.)
研究者
Zhang Bi Xiang, MD
Professor
Tongji Hospital