Advanced Hepatocellular
Conditions
Interventions
Experiment group1:Apatinib 500mg/day
Control group2:Apatinib 750mg/day
Control group:S-1
Sponsors
the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. To be conformed to meet the clinical diagnosis standard strictly or histological or cytological confirmation of PLC (primary liver cancer); 3. Patients failure or unacceptable to Sorafenib and other molecular targeted therapy; or patients with residual disease after palliative surgery (including radiofrequency ablation, microwave ablation, TACE and other minimally invasive treatment).(Failure is defined as documented radiological progression according to the radiology charter (sorafenib and other molecular targeted therapy >=14 days). Intolerance is defined as >=grade 4 hematologic toxicities, >=grade 3 non-hematologic toxicities >=grade 2 heart, liver or kidney damage); 4. First-line systemic therapy (or residual disease) must have been completed >=2 weeks before randomization (NCI-CTCAE=2000 IU/ml and under effective antiretroviral therapy; 10. Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted before enrollment (without blood transfusion, G-CSF,or drugs to correct within 14 days); HB >=80g/L; ANC>=1.5×10^9/L; PLT>=70×10^9/L; ALB >=29g/L; ALT and AST < 5×ULN; TBIL <=1.5×ULN; Cr =1.5×ULN(only one of albumin and bilirubin can score 2 in Child-Pugh); 11. Women of childbearing age must conduct pregnancy test (serum or urine) within 7 days before enrollment. If the result is negative, she must agree to use adequate contraception during the experiment and 8 weeks after the last administration of the test drugs. Men should be sterilized,, or agree to use adequate contraception during the experiment and 8 weeks after the last administration of the test drugs; 12. Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known hepatic duct carcinoma, mixed cell carcinoma or fibrolamellar hepatocellular carcinoma, known history (within 5 years) or suffering from other cancer(except of cured skin basal cell carcinoma or carcinoma in situ of cervix); 2. Patients who will receive liver transplantation (except patients with previous liver transplantation); 3. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 4. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male >=450 ms, female>=470 ms); 5. Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF=(++); 8. The Within 28 days ahead of enrollment, experience abdomen fistula, gastrointestinal perforation, or abdominal abscess; 9. Coagulation abnormalities (INR > 1.5 x ULN, or PT > ULN +4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Occurrence of central nervous system metastatic or known brain metastatic; 11. Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.; 12. Proteinuria >=(++), or 24 hours total urine protein > 1.0 g; 13. Received powerful inhibitor of CYP3A4 within 7 days or powerful inducer of CYP3A4 within 12 days before randomization; 14. Pregnant or breast-feeding women; patients with fertility will not or there is no way to adopt effective contraceptive measures; 15. Mental disorders history, or psychotropic drug abuse history; 16. Patients who has bone metastasis, have received Palliative radiotherapy (radiotherapy area > 5% marrow area).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactTaiying Lu
the First Affiliated Hospital of Zhengzhou University
Outcome results
None listed