Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Collected samples
研究概览
简要总结
Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. Moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. However, these drugs are expensive and can cause treatment-related adverse events. Therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets.
Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.
详细描述
OBJECTIVES:
- Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);
- Observe the evolution of tumors and discover specific diagnostic markers as a control group.
- Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;
- To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be older than 18 years old;
- •ECOG 0-2 points;
- •May have received treatment;
- •Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants;
- •Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;
- •Patients understand and are willing to sign written informed consent documents.
排除标准
- •The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.)
- •Pregnant women;
- •Active or uncontrollable infections (fungi, bacteria, etc.);
- •Estimated survival time <12 weeks;
- •If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days;
- •In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.
结局指标
主要结局
Collected samples
时间窗: through study completion, an average of 5 years
Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers
次要结局
- Multi-omics analysis to further type and find therapeutic targets(through study completion, an average of 5 years)
- Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors(through study completion, an average of 5 years)
- Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)(through study completion, an average of 5 years)
- Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors(through study completion, an average of 5 years)