Adjuvant Therapy With Anlotinib Hydrochloride for Patients With Hepatocellular Carcinoma Who Underwent Curative Resection: a Single Arm Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Adverse events rate
研究概览
简要总结
Patients with high risk of disease recurrence after curative resection for hepatocellular carcinoma (HCC) deserve active intervention. However, there's limited treatment choice for these patients. Anlotinib hydrochloride, a multitarget tyrosine kinase inhibitor for both tumor angiogenesis and proliferative signaling in cancer cells, is approved in China for the 3rd line treatment of advanced non-small cell lung cancer. In the current study, we are to evaluate the safety and effects of adjuvant anlotinib therapy for the patients who underwent curative resection for HCC with high risk of tumor recurrence, which is defined by Shanghai Score (Sun, et al. Chin Med J (Engl) 2017).
详细描述
Patients with high risk of disease recurrence after curative resection for hepatocellular carcinoma (HCC) deserve active intervention. However, there's limited treatment choice for these patients. Anlotinib hydrochloride, a multitarget tyrosine kinase inhibitor for both tumor angiogenesis and proliferative signaling in cancer cells, is approved in China for the 3rd line treatment of advanced non-small cell lung cancer. In the current study, we are to evaluate the safety and effects of adjuvant anlotinib therapy for the patients who underwent curative resection for HCC with high risk of tumor recurrence, which is defined by Shanghai Score (Sun, et al. Chin Med J (Engl) 2017).
The primary outcome of this study is treatment safety, and the secondary outcome is recurrence-free survival and overall survival.
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
- •Aged from 18-75 years.
- •HCC diagnosis was confirmed by pathological examination and those 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, immunotherapy, and etc.)
- •Underwent curative resection for HCC with high risk of tumor recurrence, which was defined by Shanghai Score ≥ 4.922 (Sun, et al. Chin Med J (Engl) 2017)
- •Child-Pugh class: A or B7
- •The ECOG Performance Status: 0-1 points
- •The expected survival time ≥ 6 months
- •No disease recurrence 4-6 weeks after surgery as evaluated by abdominal contrast-enhanced CT/MRI and chest CT.
- •Adequate organs function
- •Complete blood counting HB ≥ 90 g/L ANC ≥ 1.5×10^9 /L PLT ≥ 75×10^9/L
- •Blood biochemistry ALB ≥ 28 g/L ALT and AST< 5×ULN TBIL ≤ 2×ULN Serum creatinine ≤ 1×ULN
- •Women of childbearing age must have pregnancy tests 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 trial. For men, surgical sterilization should be applied, or consent to use appropriate methods of contraception 8 weeks after the trial and at the end of the trial.
- •Subjects voluntarily participated in the study, signed informed consent, good compliance in drug therapy and followed up.
排除标准
- •Cholangiocarcinoma, the combination of cholangiocarcinoma of HCC, or fibrolamellar HCC diagnosed by pathology examination.
- •Past or current diagnosed with other malignancy, except skin basal cell carcinoma and cervical carcinoma in situ.
- •Those treated with liver or other organ transplantation or willing to undergo liver transplantation.
- •The conditions not suitable for oral medications, including difficulty swallowing, chronic diarrhoea, or bowel obstruction.
- •Vascular events within 6 months, including stroke and transient ischemic attack
- •, deep venous thrombosis or pulmonary artery embolism.
- •Alimentary tract hemorrhage or high risk of alimentary tract hemorrhage due to esophageal varices, active ulcerative lesions or ulcerative colitis; or fecal occult blood test ≥ ++, or for those with fecal occult blood test (+), gastroscopy is required.
- •Abnormal coagulation function (international normalized ratio > 2, prothrombin time > 16 s, thrombin time >21s, activated partial thromboplastin time > 21 s, or fibrinogen < 2 g/L); or other conditions with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- •Other severe or uncontrolled comorbidities:
- •hypertension and the blood pressure was not well managed by medications (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 90 mmHg); level 2 or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥ 480 ms); level 1 heart dysfunction; or LVEF < 50%.
- •active or uncontrolled infection.
- •uncontrolled diabetes (fasting blood glucose > 10 mmol/L).
- •Urinary protein ≥ ++ or 24 hours urine protein > 1 g.
- •Unhealed wounds, ulcer, or bone fracture.
- •Those with mental illness or a history of psychotropic substance abuse; HIV infection.
- •Other conditions that the investigators considered that not suitable for trial inclusion.
研究组 & 干预措施
Anlotinib Hydrochloride
Oral anlotinib 12 mg/d
干预措施: Anlotinib Hydrochloride (Drug)
结局指标
主要结局
Adverse events rate
时间窗: 12 months
The rates of severity and seriousness of the adverse events. Adverse events are graded according to the NCI-CTCAE (Version 5.0)
次要结局
- Recurrence-free survival(24 months)
- Overall survival(24 months)
研究者
Hui-Chuan Sun
Professor of Surgery
Shanghai Zhongshan Hospital