Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
研究概览
简要总结
Primary Aim Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically).
Secondary Aims
- Determine the toxicity of this combination in this population.
- Determine the survival of this patient cohort treated with the combination.
- Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.
详细描述
The purpose of this study is to determine the response rate and time to progression of the combination of thalidomide, alfa interferon, and octreotide (Sandostatin LAR) in patients with unresectable hepatocellular carcinoma. If patients are eligible for and agree to take part in the study, they will be assigned to one of two treatment arms depending on SSR status. If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml
- •The tumor is unresectable
- •Performance status of < 2.0
- •> 18 years of age
- •Informed consent to be signed by patient
- •No previous treatment with thalidomide, alpha interferon, or octreotide
- •The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.
- •The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.
- •The patient must have measurable disease.
- •If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.
- •Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K
- •Patients may not have symptomatic cholelithiasis.
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Thalidomide+alpha interferon
干预措施: Thalidomide, alpha interferon (Drug)
Arm 2
Thalidomide+interferon+Octreotide
干预措施: Thalidomide, interferon, Octreotide (Drug)
结局指标
主要结局
Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
时间窗: Disease progression and toxicity
次要结局
未报告次要终点