NCT01182272Unknown2 期
Proof-of-Concept Phase II Study to Evaluate the Anti-Tumor Activity of Sorafenib Along With Pathological and Molecular Changes in Tumor Samples From Patients With Resectable Hepatocellular Carcinoma
GERCOR - Multidisciplinary Oncology Cooperative Group2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Antiangiogenic effects of sorafenib tosylate
研究概览
简要总结
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with liver cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess anti-tumor activity of neoadjuvant sorafenib tosylate in tumor samples from patients with resectable hepatocellular carcinoma (HCC).
Secondary
- To characterize pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for HCC: 1-2 core tumor biopsies will be performed prior to treatment and at day 35.
- To evaluate the number of R0 resections in these patients.
- To correlate pathological biomarker changes in resected tumors after 4-week treatment with sorafenib tosylate in comparison with biopsies obtained prior to treatment in these patients.
- To evaluate plasma biomarkers, including PIGF, VEGF-A, VEGF-C, sVEGFR2, sVEGFR3, sKIT, IL-6, Ang2, IL-8, bFGF, AFP, collagen 4, endostatin, thrombospondin, TSP-1 and angiostatin, and CXCL12 at baseline, day 28, and the day before surgery.
- To identify potential biomarkers of sensitivity and/or resistance on biological and pathological samples of these patients (exploratory).
- To characterize the safety profile of sorafenib tosylate in these patients.
- To assess the tolerance of liver resection after sorafenib tosylate treatment of these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed hepatocellular carcinoma (HCC)
- •Fibrolamellar or mixed histology allowed
- •No cholangiocarcinoma or other tubal disease
- •Must be eligible for conservative hepatic resection or liver resection with curative intent
- •No cirrhosis with Child-Pugh score > 7
- •Chronic liver disease without liver insufficiency and without portal liver hypertension allowed
- •No known history or presence of metastatic brain or meningeal tumors
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy ≥ 3 months
- •WBC > 3,000/µL
- •ANC > 1,500/µL
- •Platelet count ≥ 100,000/µL
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin < 1.5 times upper normal limit (ULN)
- •AST and ALT ≤ 5 times UNL
- •Alkaline phosphatase ≤ 5 times ULN
- •Serum creatinine < 2 times ULN
- •PT/INR/PTT < 1.5 times UNL
- •Amylase and lipase < 1.5 times ULN
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Body mass index 18.5-30 kg/m^2 (WHO normal range: 18.5-25 kg/m^2)
- •Able to swallow oral compound
- •No criterion for unresectability or medical condition that contraindicates surgical resection
- •No serious concurrent systemic disorder incompatible with the study, including any of the following:
- •Uncontrolled hypertension (i.e., BP > 150/100 mm Hg despite optimal therapy)
- •Active uncontrolled infection
- •Active alcoholism
- •No prior medical disorder, including any of the following:
- •Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or digoxin for chronic atrial fibrillation)
- •Active coronary artery disease or ischemia
- •Myocardial infarction within the past 6 months
- •NYHA class III-IV congestive heart failure
- •Pulmonary embolism within the past 6 months
- •Gastrointestinal bleeding within the past 6 months
- •No other prior malignancy within the past 5 years, except basal cell or squamous cell skin carcinoma or cured in situ cervical carcinoma
- •No history or concurrent seizure disorder requiring medications (e.g., antiepileptic drugs)
- •No history of HIV infection, or chronic hepatitis B or C
- •No active clinically serious bacterial or fungal infection (i.e., grade 2 CTCAE v. 3)
- •No condition that is unstable or could jeopardize the safety of the patient and his/her compliance with the study
- •No substance abuse or medical, psychological, or social condition that could interfere with adherence to the study
- •No known or suspected allergy to the investigational agent or to any agent given concurrently
- •No presence of asthenia or rash > CTC grade 1 at enrollment
- •Must be registered in a national health-care system
- •PRIOR CONCURRENT THERAPY:
- •No prior orthotopic liver transplantation
- •Not a candidate for orthotopic liver transplantation
- •No prior systemic or loco-regional treatment for HCC
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Antiangiogenic effects of sorafenib tosylate
Significant pathological changes
次要结局
- Pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for hepatocellular carcinoma
- Number of R0 resections
- Correlations between baseline patient characteristics, cancer biomarkers, and outcome variables and resected tumors
- Plasma biomarkers at baseline, day 28, and the day before surgery
- Safety profile of sorafenib tosylate
- Tolerance of liver resection after sorafenib tosylate treatment
研究者
研究点 (2)
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