NCT02727309Unknown1 期
A Pilot Study of Second-line Treatment With Apatinib After Trans Arterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma Patients
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma
- •Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment
- •The previous chemotherapy and the present trial registration must be at least 2 weeks apart. And they must have recovered from any toxicity of a previous chemotherapy
- •Patients with Child Pugh Class A & B disease are eligible for the study
- •Patients with Barcelona Clinic Liver Cancer stage B or C are eligible for the study
- •Eastern Cooperative Oncology Group performance score (PS): 0-2
- •Life expectancy of at least 12 weeks
- •Hepatitis B virus DNA<2000 IU/ml
- •Adequate organ function meeting the following:
- •Bone marrow: absolute neutrophil count ≥1.5×109/L (1500/mm3); platelet ≥ 75×109/L; hemoglobin ≥9 g/dL
- •Liver: Serum bilirubin ≤ 1.5 ×ULN, AST and ALT ≤ 5 ×ULN, ALB ≥ 29 g/L
- •Kidney: Cr ≤1.5 ×upper limit of normal
- •Within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward
- •Subjects who understand and voluntarily signed a written informed consent form
排除标准
- •Previous locoregional therapy within 4 weeks prior to enrollment
- •Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
- •History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
- •Prepared for liver transplantation
- •Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
- •A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence
- •Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
- •Patients with central nervous system metastases or brain metastasis
- •Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia
- •Pregnant or lactating women
- •Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment
研究组 & 干预措施
apatinib
Experimental
Patients with advanced hepatocellular carcinoma after been treated with TACE receive apatinib (750mg) daily, until disease progression or unacceptable toxicity.
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: 6 months
A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
次要结局
- Overall survival(2 years)
- Objective response rates(1.5 months)
研究者
Zhuxu
Principal Investigator
Peking University Cancer Hospital & Institute
研究点 (1)
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