NCT00471484Unknown2 期
A Phase II Trial of Oxaliplatin/Adriamycin/5 Fluorouracil in Continuous Infusion / Interferon α-2b (OXAFI) Combination as Neoadjuvant Therapy in Unresectable Non-Metastatic Hepatocellular Carcinoma
National Cancer Centre, Singapore2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2007年3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
- 54
- 试验地点
- 2
- 主要终点
- Objective tumor response rate as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy together with interferon alfa may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with unresectable, nonmetastatic hepatocellular carcinoma treated with neoadjuvant oxaliplatin, doxorubicin hydrochloride, fluorouracil, and recombinant interferon alfa-2b.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the rate of conversion to resectability of tumor in patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
- Correlate changes in serological markers of angiogenesis before and after treatment with clinical outcome in these patients.
- Correlate and validate the use of functional imaging before and after treatment with clinical outcome in 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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •Advanced, unresectable, nonmetastatic disease
- •Multifocal disease within the same lobe of the liver allowed
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •No intractable ascites that cannot be controlled by medical therapy
- •No extrahepatic metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 2.9 mg/dL
- •AST and ALT ≤ 5 times upper reference range (URR)
- •Albumin > 30 g/L
- •Creatinine ≤ 1.5 times URR
- •Creatinine clearance > 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No concurrent substantial medical illness, such as cardiac or renal disease
- •MUGA heart study normal
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study
- •No history of autoimmune disease
- •No thyroid dysfunction
- •No active hepatitis B or C flare or chronic active hepatitis
- •Hepatitis B surface antigen (HBsAg) status known
- •If HBsAg is negative, anti-HBc antibodies should be tested; if anti-HBc is positive, then hepatitis B virus (HBV) DNA detection should be performed to discern presence of mutant HBV carriage
- •No alcohol or drug abuse
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •No psychiatric illness or social situation that would preclude study compliance
- •Patients with a history of depression or psychiatric disorders are ineligible
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy and/or radiotherapy
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Objective tumor response rate as measured by RECIST criteria
次要结局
- Serum VEGF levels
- Tissue VEGF expression
研究者
研究点 (2)
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