NCT00471965已完成3 期
Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Primary:
- Overall Survival (OS)
Secondary:
- Time to Tumor Progression (TTP)
- Response Rate (RR)
- Improvement of Quality of Life (QoL)
- Safety
- Secondary resection rate
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
- •Histologically, cytologically or clinically diagnosed (in patient with cirrhosis, Alpha-Fetoprotein(AFP)≥400μg/L and morphological evidence [contrast Computed Tomography(CT)/Magnetic Resonance Imaging(MRI)] of hypervascular liver tumor, elevated AFP level due to other reasons [germ cell carcinoma, progressive chronic hepatitis, pregnancy, etc] can be excluded) unresectable hepatocellular carcinoma, ineligible or if the patient does not consent to receive local invasive treatment (chemo-embolism, ablation, etc.).
- •At least one measurable lesion (on CT: ≥2cm, on spiral CT or MRI ≥1cm)
- •Have not received previous palliative systemic chemotherapy for metastatic disease. If the patient received previous systemic chemotherapy as adjuvant treatment, he must have been completed at least 12 months previously.
- •Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 8 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
- •Karnofsky Performance Score≥70, Barcelona of Cancer Liver Category stage B/C
- •Patients must have adequate organ and marrow function:
- •Neutrophilus≥1.5X10^9/L
- •Platelets≥75X10^9/L
- •Asparagine AminoTransferase,Alanine AminoTransferase<2.5 Upper Normal Limit(UNL)
- •Total Bilirubin<1.5 UNL
- •International Normalized Ratio<1.5
- •Child stage A or B
- •Normal base line Left Ventricular Ejection Fraction (LVEF result must be above or equal to the lower limit of normal for the institution)
排除标准
- •Documented allergy to platinum compound or to other study drugs.
- •Any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization.
- •Previous liver transplantation.
- •Patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as "anti-cancer" medicine, except radiotherapy to non-target lesion (bone metastasis, etc)
- •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
- •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
A
Experimental
Oxaliplatin + 5-Fluorouracil/Leucovorin
干预措施: Oxaliplatin + 5-Fluorouracil/Leucovorin (Drug)
B
Active Comparator
Doxorubicin
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Overall survival
时间窗: From the date of randomization to the date of death due to any cause
次要结局
- Time to progression(From the date of randomization to documentation of progression)
- Response rate, secondary resection rate, quality of life(From the date of randomization to the end of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGCMalignant Neoplasm of Stomach Stage IVNCT02845908Fujian Cancer Hospital90
已完成
2 期
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With IrinotecanColorectal CancerNCT00016978National Cancer Institute (NCI)40
已完成
2 期
Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerNCT00611754Sanofi15
已完成
2 期
Oxaliplatin in Gastric CancerStomach NeoplasmsNCT00263354Sanofi20
已完成
3 期
FLOX in Combination With Cetuximab in First-line Treatment of Colorectal CancerMetastatic Colorectal CancerNCT00145314The Nordic Colorectal Cancer Biomodulation Group571