Liver Cancer
Conditions
Interventions
test group:Apatinib mesylate
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. The diagnosis of patients with locally advanced liver cancer must be based on biopsy or typical imaging findings (historical history of liver cirrhosis or chronic hepatitis B and C), strictly in line with the clinical diagnostic criteria of "Primary Liver Cancer Diagnosis and Treatment Standards" (2011 Edition) or pathological Patients with primary locally advanced HCC confirmed by histological or cytological examination, who progressed or were intolerant after first-line treatment; 3. Child-pugh liver function rating: grade A or better grade B (= 2000 IU/ml, and is taking effective antiviral therapy; 8. The adverse reactions of patients receiving previous treatment must return to normal before randomization; 9. No bleeding occurred within 2 months before enrollment; 10. The function of major organs is normal, that is, the following criteria are met: Routine examination: (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) HB>=80g/L; ANC>=1.5x10^9/L ; PLT>=70x10^9/L; Biochemical examination: (without ALB infusion within 14 days) ALB >=29 g/L; ALT and AST800mL that is not in the radiation field of radiotherapy, and there is no requirement for the maximum tumor volume or number of tumors; 12. Expected survival period >= 12 weeks; 13. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug. For males, surgical sterilization, or consent to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the trial drug; 14. Sign the informed consent form, and have the will and ability to comply with the requirements of the experimental protocol.
Exclusion criteria
Exclusion criteria: 1. Second or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia occurred within 6 months. Severe or uncontrolled systemic disease, such as clinically significant hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg), poorly controlled arrhythmias (including QTc interval >=450 ms in men and >=470 ms in women), III-IV cardiac insufficiency, according to NYHA criteria or echocardiography: LVEF = CTCAE 2 pulmonary hemorrhage or>= CTCAE 3 other organ bleeding; 4. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study; 5. Patients with CNS metastases or known brain metastases; 6. Stroke, arterial thrombosis or venous thrombosis occurred within 12 months, and taking anticoagulant drugs; 7. Received treatment with a strong CYP3A4 inhibitor within 7 days before participating in the study, or received treatment with a strong CYP3A4 inducer within 12 days before participating in the study; 8. Mental illness and psychotropic substance abuse; 9. Received other experimental drugs within 4 weeks; 10. Previously received VEGFR, platelet-derived growth factor receptor (PDGFR) and other treatments; 11. Proteinuria >= (++) or the total amount of urine protein in 24 hours > 1.0g; 12. In the past (within 5 years) or at the same time suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 13. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to disease progression;overall survival; | — |
Countries
China
Contacts
Public ContactWang Xiaoshan
Sichuan Provincial People's Hospital
Outcome results
None listed