NCT00051532终止不适用
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- Overall survival, defined as the time from start of treatment to death
研究概览
简要总结
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Aged 18-75 years
- •With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
- •Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.
排除标准
- •Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
- •Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
- •A history of renal stone(s)
- •A life expectancy of < 3 months
- •World Health Organization (WHO) performance status 3 or 4
- •Okuda stage III.
- •Patients with hypercalcemia, or other clinically important laboratory abnormalities
- •Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
- •All patients must give their signed informed consent to join the study.
结局指标
主要结局
Overall survival, defined as the time from start of treatment to death
次要结局
- Time to response from start of treatment (complete or partial response)
- Change in tumour marker
- Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded
- HCC-specific survival from start of treatment
- Time to progression measured from start of treatment
- Proportion of patients who achieve partial/complete response
- Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed
- Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
- Change(s) in tumour size
- Change in laboratory values
- Number of days of hospitalisation (in-patient care)
- Quality of life
- Adverse events
- Dose of seocalcitol (seocalcitol treated patients)
研究者
研究点 (10)
Loading locations...
相似试验
终止
3 期
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular CarcinomaLiver NeoplasmsNCT00051545LEO Pharma608
终止
2 期
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT00351195Rigshospitalet, Denmark39
终止
2 期
Chemoembolization for Hepatocellular CarcinomaHepatocellular CarcinomaNCT02821533Chinese University of Hong Kong24
撤回
不适用
Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular CarcinomaHepatocellular CarcinomaNCT01489410University of Minnesota
已完成
4 期
Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACECarcinoma, HepatocellularNCT00936689Rita Golfieri178