advanced HCC
Conditions
Interventions
experimental group :Apatinib mesylate tablets + radiotherapy
control group :radiotherapy
Sponsors
Tangdu Hospital of Fourth Medical University of Chinese PLA.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. The abdominal ultrasound, CT, DSA imaging diagnosis of intrahepatic placeholder; 3. The Karnofsy > 70; 4. The Child - Pugh, liver function grade: good grade A or B (7 points) or less; 5. BCLC stage for B - C; 6. The expected to survive period is 12 weeks or more; 7. Major organs function is normal, which meet the following criteria: (1) the blood routine examination (within 14 days before the screening without blood transfusion, unused g-csf, unused drugs to correct): HB 90 g/L or higher; ANC acuity 1.5 x 10^9/L; PLT acuity 80 x 10^9/L; and biochemical examination propagated loss (14 days): propagated 29 g/L or higher; ALT and AST < 5 uln; TBIL ULN 1.5 or less; creatinine 1.5 ULN or less; 8. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception.For men, should be sterilization surgery, or agreed to during the test and the last for 8 weeks after experimental drug using appropriate method of contraception; 9. Willing to join in this study, subjects signed informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. In the four weeks before the study received surgery, chemotherapy, biological treatment; 2. Severe decompensated liver function, such as jaundice, moderately severe ascites, moderately severe hypoalbuminemia patients with severe ascites, which need to be treated abdominal puncture and drainage; 3. 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); 4. Combined with acute myocardial infarction (ami), sinus bradycardia, II magnitude atrioventricular block and so on serious heart disease;According to the NYHA standard III ~ IV level cardiac insufficiency or heart colour to exceed examination: LVEF, left ventricular ejection fraction 1.5 or prothrombin time (PT) > ULN + 4 seconds), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Routine urine showed that urinary protein p + + or confirmed 24 hours urinary protein quantitative > 1.0 g; 10. The study the 7 days before the received potent CYP3A4 inhibitor treatment, or be involved in research of 12 days before received potent CYP3A4 inducers treatment; 11. Pregnant or lactating women;Patients with fertility unwilling or unable to take effective contraceptive measures; 12. Have a mental illness, or psychiatric history of drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| os;DCR;ORR;AFP;Qol;AE; | — |
Countries
China
Contacts
Public ContactYu Zongyan
Tangdu Hospital of Fourth Medical University of Chinese PLA.
Outcome results
None listed