Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- treatment response
研究概览
简要总结
Observational Model: Cohort Time Perspective: Other (prospective and retrospective data/sample collection) Primary Purpose: Other (biomarker validation for treatment response and recurrence prediction) Biospecimen Retention: Samples With DNA Biospecimen Description: Residual tissue, wax blocks/slides, residual puncture/surgical materials, and residual blood from routine testing; additional peripheral blood, 5-10 mL per collection, may be collected if needed after separate informed consent.
Enrollment: 500 (anticipated) Study Population: Adult patients with HCC confirmed by imaging and/or pathology at participating centers, receiving standard antitumor therapy and planned for systematic follow-up.
Sampling Method: Not specified in the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female aged ≥18 years.
- •HCC confirmed by imaging and/or pathology according to current Chinese guidelines.
- •3. Receiving standard antitumor therapy, such as surgery, ablation, TACE, targeted therapy, and/or immunotherapy, at participating centers and planned for systematic follow-up.
- •4. ECOG performance status 0-2; expected survival ≥3 months.
- •Child-Pugh class A or stable B; major organ function basically compensated.
- •Agrees to provide or authorize use of available clinical data, imaging/pathology information, residual tissue/wax blocks/slides from routine care, and/or residual blood samples. If additional peripheral blood collection is required, the purpose, volume, risks, sample use, and compensation arrangements will be specified in the informed consent form, and the participant must sign a separate written informed consent.
排除标准
- •1. Active malignancy at other sites, or history of other malignancy within 5 years, except cured in situ carcinoma and basal cell skin carcinoma.
- •2. Prior liver transplantation or known immunodeficiency disease.
- •Severe heart, lung, renal, or other major organ dysfunction, or uncontrolled severe infection, unable to tolerate routine antitumor therapy and follow-up.
- •4. Decompensated liver function, such as obvious refractory ascites or hepatic encephalopathy, or Child-Pugh class C.
- •5. Pregnant or breastfeeding women, or women planning pregnancy who refuse effective contraception.
- •6. Severe mental disorders or extremely poor compliance, unable to complete follow-up and specimen collection.
- •7. Other conditions considered unsuitable for inclusion by the investigator.
研究组 & 干预措施
No investigational
干预措施: No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research. (Other)
结局指标
主要结局
treatment response
时间窗: 1 year
Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response
Association between candidate biomarker expression/levels and recurrence/progression risk
时间窗: From baseline to end of follow-up
Correlation between biomarker results and recurrence/progression events, including PFS/RFS
次要结局
- Progression-free survival (PFS)(1 year)
- Overall survival (OS)(2 year)
- Dynamic changes in alpha-fetoprotein (AFP)(1 year)