Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Apatinib

Criteria

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;