NCT00559455已完成2 期
Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan
研究概览
简要总结
Primary objective:
To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV
Secondary objective:
To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Documented allergy to platinum compound or to other study drugs.
- •Active Gastro-Intestinal bleeding and active haematologic malignancy
- •Previous liver transplantation.
- •Patients concomitantly receiving any other anti-cancer therapy.
- •Patients who are receiving any other study treatments.
- •Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
- •History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- •Central nervous system metastasis
- •Other serious illness or medical conditions
- •Neuropathy ≥ grade 2
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Oxaliplatin (Drug)
1
Experimental
干预措施: Fluorouracil (Drug)
1
Experimental
干预措施: Leucovorin (Drug)
结局指标
主要结局
Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan
时间窗: every 6 weeks
次要结局
- Time to Progression (TTP), 6 month survival, overall survival, AFP(from the signature of Informed Consent up to end of the study)
研究者
研究点 (1)
Loading locations...
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