NCT00051545终止3 期
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 608
- 试验地点
- 10
- 主要终点
- Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
研究概览
简要总结
To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for 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
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital in- or out patients
- •Either sex
- •18 to 75 years of age
- •With hepatocellular carcinoma treated successfully with surgical resection or percutaneous ablative treatment within 4 and 8 weeks, respectively, prior to inclusion.
- •All patients must give their signed informed consent to join the study.
排除标准
- •Patients previously treated with any anti-cancer therapy for HCC except for surgical resection and percutaneous ablative therapy
- •Patients treated with chemotherapy or other anti-cancer therapy (except surgical resection or percutaneous ablative treatment) in the previous 4 weeks
- •Patients with another primary tumor except basocellular carcinoma of the skin or in situ carcinoma of the cervix within the last 2 years
- •With a history of renal stone(s)
- •With a life expectancy < 3 months
- •WHO performance status 3 or
- •Patients with hypercalcemia (ionised serum calcium > 1.35 mmol/l or albumin corrected serum calcium > 2.68 mmol/l), previous/current calcium metabolic disease, taking calcium-lowering therapy or medication known to affect systemic calcium metabolism, or with marked laboratory abnormalities.
- •Patients with recurrent hepatocellular carcinoma, with known extrahepatic metastases, Okuda stage III disease and patients with a Child-Pugh score of C are also excluded.
结局指标
主要结局
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
次要结局
- Survival
- Time to distant recurrence of HCC
- Time to second primary HCC
- Time to development of metastases
- Tumour measurements
- Tumour marker (alpha-fetoprotein AFP)
- Quality of life
- Length of hospital stay
- Adverse events
- Laboratory safety examinations
- Dose of Seocalcitol
研究者
研究点 (10)
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