primary carcinoma of liver
Conditions
Interventions
single arm:Apatinib 500mg orally, qd, d1-21, with 21 days as a cycle
raltitrexed , 3 mg/m2,?1?,????15 min
????130 mg/m2,d1, with 21 days as a cycle
Sponsors
Department of Oncology, Guigang City People’s Hospital, The Eighth Affiliated 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. Patients have received radiotherapy or chemotherapy within four weeks before the study; 2. In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted; 3. Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg); 4. Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms); 5. There are many factors which can influence the oral drug absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption); 6. Within 6 months in the past,the patients have a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency, for example,there is a risk of bleeding of esophageal varicose veins, local active ulcerative lesions, defecate occult blood = (+ +)(+) shall not be admitted into the study; 7. Within 28 days before being admitted into the study, there is abdominal fistula, gastrointestinal perforation or abdominal abscess; 8. Blood coagulation function is abnormol (INR>1.5 or PT> ULN+4s), and the patients are able to be faced with a bleeding tendency or being treated with thrombolysis and anticoagulation; 9. Has been diagnosed with ?the central nervous system metastases or the brain metastases has been known; 10. There are past medical history or history of present illness of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia,?pulmonary function test suggests there is objective evidence of severely damaged lung function; 11. Urine routine inspection suggests that the urine protein =++;24 hours urine protein examination>1.0 g; 12. Within 7 days before being admitted into the study,patients have received a potent CYP3A4 inhibitor treatment, or within 12 days before being admitted into the study,patients have received potent CYP3A4 inducers treatment; 13. Pregnant or lactating women;Patients with fertility are unwilling or unable to take effective contraceptive measures; 14. With a mental illness, or has a history of psychiatric drugs abuse; 15. patients with HIV infection.
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 ContactHaizhen Yi
Department of Oncology, Guigang City People’s Hospital, The Eighth Affiliated Hospital of Guangxi Medical University
Outcome results
None listed