primary carcinoma of liver
Conditions
Interventions
Case series:Apatinib 500mg orally, qd, d1-28, with 28 days as a cycle
S-1, 20mg orally, bid, d1-28, with 28 days as a cycle
Both drugs take until the disease progression or untolerable toxicities occurred
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study, and signe informed consent; 2. Aged from 18 to 75 years; 3. The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-2; 4. The diagnosis of PLC must be in line with the "Guidelines for Primary Liver Cancer" (2011 edition, Ministry of Health's Medical Administration ,The Peoples Republic of China); 5. Child-Pugh score A or B; 6. BCLC staging (Barcelona staging) B-C; 7. Unfit or refuse to undergo surgical resection or transcatheter arterial chemoembolization, and never receive systemic chemotherapy and molecular targeting therapy; 8. At least one measurable lesion according to RECIST (version 1.1) [spiral CT scan =10 mm(CT scanning slice ? 5 mm), which never recieved radiotherapy or other local therapy, or progressed after these treatment]; 9. Expected survival = 3 months; 10. The main organs function normally, that is, meeting the following criterias: Hb=90 g/L(No blood transfusion; within 14 days), ANC=1.5×10^9/L; PLT=75×10^9/L, TBIL=1.5×ULN (Upper limit of normal), ALT, AST=5×ULN, Serum Cr=1.5×ULN; 11. Women of childbearing age must undergo a pregnancy test (serum or urine) 7 days before enrollment and have a negative result, and they are willing to take appropriate methods for contraception at trial period and 8 weeks after last administration of trial drugs.
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating women; 2. Participated other clinica study in past four weeks; 3. History of with other malignancy in the past 5 years, except for cured skin basal cell carcinoma and carcinoma in situ of cervix; 4. Patients who plan for liver transplantation (except those who had previously undergone liver transplantation); 5. Patients with high blood pressure and antihypertensive drug treatment can't obtain good control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), preexisting severe cardiovascular disease: grade ? myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including women whose QTc interphase is 470 ms or longer); According to NYHA standard, ?? cardiac insufficiency, or colour doppler ultrasound revealed left ventricular ejection fraction (LVEF) 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), receiving thrombolysis or anticoagulation therapy, bleeding tendency, or exists explicit gastrointestinal or other organs hemorrhage concerns (such as: local active ulcerative lesions, etc.); 10. Any arterial /venous thromboembolism events occured 6 months before joining in the study, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis or pulmonary artery embolism, etc.; 11. A long-unhealed wound or fracture in the body; 12. The routine urinalysis suggests that the urine protein is + + or higher and 24-hour urine protein quantitatively > 1.0 g; 13. Severe or uncontrolled infection (NCI-CTCAE 4.03 > 2); 14. patients who has a history of psychotropic substance abuse and is unable to quit or has a history of mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);disease control rate (DCR);over-all survival (OS);safety; | — |
Countries
China
Contacts
Public ContactZhihui Liu
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed