NCT01192971已完成2 期
Randomized, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- TTP (Time to Progression)
研究概览
简要总结
This phase II trial will be studying how well Apatinib working in patients with 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
- •Histologically or cytologic confirmed advanced hepatocellular carcinoma
- •Patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib.
- •Life expectancy of more than 12 weeks.
- •ECOG performance scale 0 -
- •Child -Pugh score A，BCLC stage B or C.
- •At least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral CT scan, conforming to RECIST 1.1).
- •Have not received systemic chemotherapy or molecular targeted therapy. At least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (ADRs) or wounds have completely healed. At least 6 months must have elapsed for patients who have received adjuvant chemotherapy.
- •Adequate organ functions (hemoglobin≥ 90g/L ,platelets ≥80 × 109/L, neutrophil≥ 1.5 × 109/L, albumin ≥ 29 g/L, Plasma creatinine ≤ 1.5 × ULN , ALT and AST< 5 × ULN; TBIL ≤ 1.5 × ULN.
- •Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Pregnant or lactating women.
- •Patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption.
- •Evidence of CNS metastasis.
- •Subjects with hypertension which cannot be well controlled by antihypertensives; grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades III to IV according to NYHA criteria; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) of < 50%.
- •Subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy.
- •Definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months.
- •Patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a Child-Pugh score of ≥ 2.
研究组 & 干预措施
A: 850mg
Experimental
A: Experimental apatinib 850 mg qd p.o, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Apatinib (Drug)
B: 750mg
Experimental
B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Apatinib (Drug)
结局指标
主要结局
TTP (Time to Progression)
时间窗: 8 weeks
次要结局
- Serum alpha-fetoprotein (AFP) level(8 weeks)
- QoL (quality of life): EORTC QLQ-C30(8 weeks)
- DCR (Disease control rate(8 weeks)
- ORR (objective response rate)(8 weeks)
- Overall Survival(8 weeks)
研究者
研究点 (1)
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