NCT00082082已完成2 期
A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial
SciClone Pharmaceuticals9 个研究点 分布在 1 个国家开始时间: 2004年4月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 9
研究概览
简要总结
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent.
- •Diagnosis of HCC by:
- •Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by:
- •A new hepatic defect on imaging with an AFP > 1000 ng/ml, or
- •A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:
- •At least two additional imaging techniques show signs characteristic of HCC, or
- •The new hepatic defect has doubled in diameter over time, or
- •The AFP has progressively risen to > 200 ng/ml and triples the mean baseline.
- •HCC must be unresectable and non-transplantable.
- •Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L.
- •Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl.
- •If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.
排除标准
- •Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient).
- •Presence of main portal vein thrombosis or hepatic artery malformation.
- •HCC amenable to treatment by surgical resection or hepatic transplantation.
- •HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
- •Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
- •Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature.
- •Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study.
- •Alcohol or intravenous drug abuse within the previous 1 year.
- •Previous treatment with thymalfasin.
- •Patients with known hypersensitivity to iodine.
- •Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
研究者
研究点 (9)
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