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Patients participate in the study voluntarily and sign informed consent with good compliance |
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Histological or cytological confirmation of unrespectable middle-advanced hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage Category C or B , liver function child-Pugh class A or B (7 points) |
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At least one measurable lesion, with diameter 10mm measured by spiral MRI/CT scan per mRECIST; have not received local therapies including but not limited to TACE, RFA, radiotherapy and cryosurgery.-Eastern Cooperative Oncology Group Performance Status 0 or 1 |
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Life expectancy of at least 3 months |
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Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) 90 g/L, Neutrophils (ANC) 1.5109/L, leucocyte (WBC) 3.0109/L, Platelet count (PLT) 70109/L, Total bilirubin (TBIL) 1.5 normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) 2.5 ULN, Serum creatinine (Cr) 1.5 ULN or Creatinine Clearance rate(CCr) 60ml/min,Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%) |
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The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it |
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Patients have disease that is not amenable to potentially curative transplantation or ablation |
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Patients who have characterization for targeted therapy treatment, but under poor economic conditions and cannot afford angiogenesis inhibitors recommended by current guidelines, including Lenvatinib, sorafenib, Cabozantinib, Ramolumab, regorafenib, etc |
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History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms)
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Subject has obstacle in the function of major organs such as heart, lung, liver and kidney
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Patients who plan liver transplantation
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Patients who had previously received treatment with target inhibitors or other immunotherapy against or chemotherapy
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Patients who had previously received treatment with TACE or or other local therapy or radiotherapy or Chinese medicine treatment within 4 weeks
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Liver function status Child-Pugh Class C, with malignant ascites
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Participated in other anti-tumor clinical trials within 4 weeks
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Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
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Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, nternational normalized ratio (INR)>1.5
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Patients who underwent major surgery within 4 weeks
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Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0)
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Patients with any severe and/or unable to control diseasesincluding Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure 150 mmHg or diastolic blood pressure 100) mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc480ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ++, and confirmed 24-hour urine protein quantitation > 1.0 g
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Patients whose tumors had invaded important blood vessels by imaging or who, as determined by the researchers, were likely to invade important blood vessels during follow-up trial, resulting in fatal bleeding
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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
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Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers
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Patients with Brain metastases
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Patients with cancer thrombus involving whole the main portal vein
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Female patients who are pregnant or breastfeeding
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Patients with drug abuse history and unable to get rid of or patients with mental disorders
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Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
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History of gastrointestinal bleeding due to severe gastroesophageal varices within 4 weeks
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Severe active or uncontrolled infections
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Patients who had serious adverse effect to Anlotinib
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Patients who had serious adverse effect to iodinated contrast agent
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Liver cirrhosis, hepatic decompensation, active hepatitis or chronic hepatitis which requires anti-viral treatment. Hepatitis C virus (HCV) antibody test shows positive and titer test shows amount of HCV exceeds upper limit of normal (ULN) after treatment
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