NCT02809534Unknown2 期
A Single Group, Open Label, Single-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 12-week Progression-free survival rate(PFR 12w)
研究概览
简要总结
To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC).
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
- •Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of hepatocellular carcinoma who cannot benefit from treatments of ablative therapy
- •Liver function status Child-Pugh Class A or B (score≤8)
- •Enroll 2 group patients：Group A：No history of systematic chemotherapy/target therapy.Group B:Failed with Sorafenib(Last Sorafenib Therapy≥4 weeks )
- •Last Therapy≥4 weeks (such as surgery, PCI,ablation, radiotherapy)，and the wound healing.Patients with adjuvant chemotherapy, last chemotherapy ≥6m
- •At least one measurable lesion (by RECIST1.1)
- •18-75 years,ECOG PS:0-1,Life expectancy of more than 3 months
- •Main organs function is normal
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- •Patients should participate in the study voluntarily and sign informed consent
排除标准
- •Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
- •History of other malignancy (except for non-melanoma skin cancer, cervix in situ carcinoma)
- •Liver function status Child-Pugh Class C (score>9),with malignant ascites
- •HBV-DNA>2000IU/mL
- •History of liver transplantation or prepare for it
- •Patients with any severe and/or unable to control diseases，including：
- •Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- •Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
- •Patients with active or unable to control serious infections;
- •Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
- •Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
- •Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- •Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
- •Patients participated in other anticancer drug clinical trials within 4 weeks
- •History of immunodeficiency
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
研究组 & 干预措施
Anlotinib
Experimental
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
结局指标
主要结局
12-week Progression-free survival rate(PFR 12w)
时间窗: From randomization，each 42 days up to PD or death(up to 24 months)
次要结局
- Time to Progression(TTP)(From randomization，each 42 days up to PD or death(up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Serum Alpha-Fetoprotein level (AFP)(From randomization up to 24 months)
- Overall Survival (OS)(From randomization until death (up to 24 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- 24-week Progression-free survival rate(PFR 24w)(From randomization，each 42 days up to PD or death(up to 24 months))
研究者
研究点 (1)
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