cancer
Conditions
Interventions
Sponsors
the First affiliated Hospital of SooChow University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Strictly comply with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition) clinical diagnosis standard or by pathological histology or cytologic examination of diagnosis of primary HCC patients or patients with unresectable HCC recurrence/metastasis, and can't accept palliative surgery or radiation therapy, and at least one measurable lesions (according to the request of RECIST 1.1 the measurable lesions spiral CT scan length to diameter 10 mm or swollen lymph nodes or short diameter 15 mm or higher);The biggest tumor 10 cm or less; 3. The Child - Pugh, liver function grade: good grade A or B (7 points) or less; Stage 4. BCLC staging for B or C; 5. In group 1 weeks before ECOG PS score: 0 and 1; 6. Is expected to survive a period of 12 weeks or more; 7. Major organs function is normal, which meet the following criteria: (1) blood routine inspection: A) HB or 60 g/L; B) the ANC acuity 1.0 x 10^9/L; C) PLT 60 x 10^9/L or higher; (2) and biochemical examination: A) the ALT and AST < 5' ULN. B) TBIL 1.5 or less' ULN. C) creatinine 1.5 or less' ULN. (Child - Pugh, albumin and bilirubin in rating two indicators can only have a 2 points); 8. Women of childbearing age should be in the group of 7 days before the pregnancy test; 9. In line with the conventional indications; 10. Subjects were willing to join in this study, signed informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. In the study of four weeks before received anything other than the conventional local treatment (including but not limited to surgery, radiotherapy, hepatic artery thrombosis, hepatic artery perfusion, radiofrequency ablation and cryoablation or percutaneous ethanol injection); 2. Known hepatic duct carcinoma and mixed cell carcinoma and fiberboard layer cell carcinoma;Past (5 years) or at the same time with other malignant tumor, not cure to have cured except skin basal cell carcinoma and cervical carcinoma in situ; 3. Prepare for a liver transplant patients (always except for liver transplantation patients); 4. Patients with clinical symptoms of ascites, namely therapeutic abdominal puncture or drainage, or a Child - Pugh score > 2; 5. People with high blood pressure and antihypertensive drug therapy can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Level is above 6. With ? myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); 7. With a variety of factors influencing oral drugs (such as unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorb); 8. Within the past 6 months have a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as: there is a risk of bleeding of esophageal varices, local active ulcerative lesions, defecate occult blood or greater (+ +) shall not enter into group;Requirements such as defecate occult blood (+), gastroscopy; 9. In this study appeared within 28 days before the abdominal fistula, gastrointestinal perforation or abdominal abscess; 10. Coagulant function abnormality, with bleeding tendency or is treated with thrombolysis and anticoagulation; 11. Has been known or transfer of the central nervous system activity in patients with brain metastasis; 12. And now a past medical history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, pulmonary function was seriously damaged the objective evidence of patients; 13. Routine urine showed that urinary protein p + + or confirmed 24 hours urinary protein quantitative > 1.0 g; 14. The study the 7 days before the received potent CYP3A4 inhibitors (including erythromycin, clarithromycin, josamycin, acetylspiramycin, so wei, itraconazole, ketone health zun, nika horizon, sulfur, and verapamil and Bella in) treatment, or be involved in research of 12 days before received potent CYP3A4 inducers treatment; 15. Pregnant or lactating women;Patients with fertility unwilling or unable to take effective contraceptive measures; 16. Has a mental illness, or psychiatric history of drug abuse; 17. Have occurred in patients with bone metastases, in four weeks before the study received palliative radiotherapy (radiation area > 5% bone marrow area); 18.Joint patients with HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AFP; | — |
Countries
China
Contacts
Public ContactZhu xiaoli and Ni caifang
the First affiliated Hospital of SooChow University
Outcome results
None listed