NCT02534337撤回2 期
Gemcitabine Plus Oxaliplatin (GEMOX) Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
Guangxi Medical University0 个研究点开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX) is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were age 18 to 75 years;
- •The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
- •ECOG score≤2;
- •life expectancy 3 months;
- •Barcelona Clinic liver cancer (BCLC) stage B or C disease;
- •Child-Pugh stage A or B disease;
- •Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin <1.5×ULN, international normalized ratio <1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range.
- •Patients had to provide signed informed consent to participate.
排除标准
- •documented allergy to platinum compounds or other study drugs; any previous OXA or GEM treatment, except adjuvant treatment ﹥12 months before random assignment;
- •Previous liver transplantation;
- •concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
- •CNS metastasis;
- •Other serious illness or medical condition.
研究组 & 干预措施
GEMOX
Experimental
gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2.
干预措施: GEMOX (Drug)
FOLFOX4
Active Comparator
Oxaliplatin 85 mg/m2 intravenously on day 1; Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2.
干预措施: FOLFOX4 (Drug)
结局指标
主要结局
Progression-Free-Survival
时间窗: 3 months
次要结局
- Disease control rate(3 months)
- Overall survival(6 months and 12 months)
- Objective response rate(3 months)
- Time-to-Progression(3 months)
研究者
Chengcheng Liao
Chengcheng Liao, Affiliated Tumor Hospital, Guangxi Medical University
Guangxi Medical University
相似试验
Unknown
3 期
Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic CholangiocarcinomaCholangiocarcinomaNCT02548195Shanghai Zhongshan Hospital286
已完成
3 期
Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)Carcinoma, Non-Small-Cell LungNCT00087802Sanofi383
终止
2 期
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial TractCarcinoma, Transitional CellNCT00127595Gustave Roussy, Cancer Campus, Grand Paris28
终止
2 期
A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast CancerBreast CancerNCT00674206Emory University6
终止
2 期
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast CancerRecurrent Breast CancerMetastastic Breast CancerNCT00159458University of Southern California7