Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma (HCC)

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Apatinib, advanced hepatocellular carcinoma Read More

Inclusion Criteria:

1. Age: 18-70 years old;
2. initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
3. Child-pugh liver function Rating: A level, B level;
4. BCLC Staging as B / C period;

5. before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:

   1. HB≥90 g/L;
   2. ANC≥1.5x109/L;
   3. PLT≥60x109/L; ( 2 ) Biochemical Examination:
   1. ALB≥29 g/L;
   2. ALT and AST<2.5*ULN;
   3. TBIL ≤ 2*ULN;
   4. Cr ≤ 1.5*ULN;
6. women of childbearing age must be pregnancy tests before join in the group in 7 days;
7. Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.

Exclusion Criteria:

1. Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
2. hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ;
3. clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure > 140 mmHg , diastolic pressure >90 mmHg );
4. Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
5. Follow NYHA Standard Ⅲ ~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) < 50% ;
6. There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption);
7. previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy;
8. before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day;
9. Coagulation dysfunction ( INR > 1.5 or prothrombin time ( PT ) > ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy;
10. patients who have undergone central nervous system metastasis or known brain metastases;
11. patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment;
12. urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration > 1.0 g ;
13. before participating in the study 7 days use strong-effect in CYP3A4 inhibitor therapy, or prior to participating in the study 12 days use the strong-effect in CYP3A4 inducer Therapy;
14. pregnant or lactating women who are not willing or unable to take effective contraceptive measures;
15. A history of mental illness, or psychotropic substance abuse;
16. Union HIV infected patients;