NCT02527772撤回2 期
Liposomal Doxorubicin(LD) Plus Gemcitabine 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 Liposomal Doxorubicin(LD) plus Gemcitabine(GEM) is superior to Oxaliplatin（OXA） 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 DOX 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
Liposomal Doxorubicin+Gemcitabine
Experimental
Gemcitabine 1000mg/m2,d1,8;Liposomal Doxorubicin 30mg/m2,d1.q4w
干预措施: Liposomal Doxorubicin+Gemcitabine (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, once every 2 weeks
干预措施: FOLFOX4 (Drug)
结局指标
主要结局
Progression-Free-Survival
时间窗: 6 months
次要结局
- Objective response rate(3 months)
- Overall survival(6 months and 12 months)
- Disease control rate(3 months)
- Time-to-Progression(3 months)
研究者
Chengcheng Liao
Affiliated Tumor Hospital
Guangxi Medical University
相似试验
Unknown
3 期
Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:Acute Lymphoblastic LeukemiaNCT02070523Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.200
已完成
2 期
Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast CancerBreast CancerNCT00960336ARCAGY/ GINECO GROUP59
已完成
2 期
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDSSarcoma, KaposiHIV InfectionsNCT00001059National Institute of Allergy and Infectious Diseases (NIAID)120
招募中
1 期
Combination Therapy for Recurrent Ovarian CancerRecurrent Ovarian CancerNCT05610735Sham Sunder Kakar72
Unknown
4 期
A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler ImagingBreast CancerNCT00531973Catholic University, Italy80