Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biomarkers predictive
研究概览
简要总结
To explore biomarkers predictive of clinical response to sorafenib in unresectable hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells.
To identify negative predictive markers to sorafenib. To elucidate signal transduction pathway attributable to sorafenib resistance. To monitor changes in the RTK activation status during sorafenib treatment using circulating tumor cells.
To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to sorafenib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein > 400ng/mL and liver cirrhosis
- •Inoperable disease as defined by (Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR Presence of extra-hepatic disease OR Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR The HCC must not be amenable to intra-arterial therapy or local ablative therapy)
- •Minimum life expectancy of 12 weeks
- •Age > 18 years.
- •ECOG Performance Status of ≤ 2
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •(Hemoglobin > 9.0 g/dl,Absolute neutrophil count>1,500/mm3, Platelet count>75,000/μl,Total bilirubin < 1.5 times the upper limit of normal,ALT and AST < 5 x upper limit of normal,Albumin ≥ 3g/dL,PT-INR/PTT < 1.5 x upper limit of normal,Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥ 50mL/min)
- •Signed and dated informed consent before the start of specific protocol procedures.
- •FNA will be performed in patients with feasible biopsy site
排除标准
- •Decompensated cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
- •Other concomitant anticancer agent, including Tamoxifen and Interferon
- •Active clinically serious infections (> grade 2 CTCAE version 3.0)
- •History of organ allograft
- •Patients with evidence or history of bleeding diasthesis
- •Patients undergoing renal dialysis
- •Radiotherapy during study or within 4 weeks of start of study drug.
- •Prior exposure to the study drug.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
结局指标
主要结局
Biomarkers predictive
时间窗: 36months
To explore biomarkers predictive of clinical response to sorafenib in unresectable hepatocellular carcinoma using the Prometheus Platform A. To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to sorafenib
次要结局
- Signal transduction pathway(36months)
- The RTK activation status.(36months)
研究者
Ho Yeong Lim
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Samsung Medical Center