NCT03261791Unknown2 期
A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- recurrence-free survival
研究概览
简要总结
In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein tumor thrombus.
详细描述
Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.
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
- •Aged from 18-70 years.
- •HCC diagnosis confirmed by pathological examination who did not receive anti-tumor treatment (anti-tumor treatment including but not limited to: local ablation therapy, TACE, radiation therapy, chemotherapy, targeted drug therapy, etc.)
- •Underwent radical resection for hepatocellular carcinoma with portal vein tumor thrombus, as assessed by preoperative imaging or intraoperative findings, within 4 weeks
- •Child-Pugh class: A or B7
- •The ECOG: 0-1 points
- •The expected survival time ≥ 6 months.
- •Main organs function is normal including:
- •blood routine examination
- •HB ≥ 90 g/L
- •ANC ≥ 1.5×109 /L
- •PLT ≥ 80×109/L
- •biochemical test
- •ALB ≥ 29 g/L
- •ALT<3 ULN and AST< 3 ULN
- •TBIL ≤ 1.5 ULN
- •Serum creatinine ≤ 1.5 ULN；
- •Women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to use appropriate methods of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial;
- •subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
排除标准
- •Hepatic duct carcinoma、mixed cell carcinoma and fiberboard layer cell carcinoma which have confirmed; Past (5 years) or current with other malignant tumor, except skin basal cell carcinoma and cervical carcinoma in situ.
- •Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg).
- •With the second level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 ms).
- •Factors that affect oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs.
- •Ascites with clinical symptoms requires therapeutic peritoneal paracentesis or drainage.
- •In the past 6 months, with the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency, such as: the risk of bleeding esophageal varices, local active ulcerative lesions, fecal occult blood; For those with fecal occult blood (+), gastroscopy is required.
- •Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before entry;
- •Postoperative complications were not relieved.
- •Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy;
- •Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment;
- •Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g;
- •Symptomatic metastasis of the central nervous system;
- •Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives;
- •Patient with mental illness or a history of psychotropic substance abuse;
- •HIV infection;
- •Before operation, AFP or PIVKA-2 increased, but not decreased to normal range;
- •HBV-DNA>10^3 copys/ml；
- •Other conditions that the investigators considered that not unsuitable for inclusion.
研究组 & 干预措施
Apatinib
Experimental
Apatinib mesylate tablets 500 mg po qd.
干预措施: Apatinib (Drug)
结局指标
主要结局
recurrence-free survival
时间窗: 24 months
From the date of liver surgery to the date of diagnosis of tumor recurrence
次要结局
- overall survival(24 months)
- safety: the potential side effects(24 months)
研究者
研究点 (1)
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