Hepatocellular carcinoma
Conditions
Interventions
none:Apatinib 250mg/Day
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged at least 18 years; 2. The clinical diagnosis of HCC newly but no extrahepatic metastasis or major vascular invasion; 3. Patients with high Risk of recurrence in 3-7 weeks after surgery as assessed by clinician; 4. Untreated with Anti-HCC therapy; 5. Child-Pugh score =7; 6. ECOG score 0-1 in 1 week before enrollment; 7. Adequate?mayor organs function as following items: (1) blood routine examination HB=90 g/LANC=1.5×10^9/L; PLT=60×10^9/L (2) Blood biochemical examinationALB =29 g/L; ALT and AST<5 ULN; TBIL =1.5/ULN; Creatinine=1.5/ULN; 8. Intermediate or High Risk of recurrence; 9. Patients must offer signed informed consent and cooperate with the follow-up visit.
Exclusion criteria
Exclusion criteria: 1. Recurrent HCC; 2. Low risk of recurrence after curative treatment; 3. With history of other chemotherapy in 4 weeks before enrollment; 4. In the past (5 years) or at the same time with other uncured malignant tumoursexcept for cured skin basal cell carcinoma and cervical carcinoma in situ; 5. uncontrolled hypertension; 6. Arrhythmia that needs anti-arrhythmia therapy (beta receptor blocker and digoxin could be accepted) With above level II myocardial ischemia or myocardial infarctionuncontrolled arrhythmia; 7. Many factors that influence the oral drugs; 8. With history of gastrointestinal bleeding in the past 6 months or a gastrointestinal bleeding tendency, such as: there is a risk of bleeding of esophageal varices, local active ulcerative lesions, defecate occult blood =(+ +) shall exclude ;As defecate occult blood(+), request for gastroscopy; 9. History of abdominal fistula, gastrointestinal perforation or abdominal abscess with 28 days before enrollment; 10. Coagulant function abnormalityWith bleeding tendency or is treated with thrombolysis and anticoagulation 11. CNS metastases or Brain metastases; 12. Urine protein= ++ or 24-hour urinary protein quantity>1.0g; 13. History of the potent CYP3A4 inhibitor treatment in 7 days before enrollmentor potent CYP3A4 inducers treatment in 12 days before enrollment; 14. In pregnant or lactating Female; 15. History of Mental illness or Psychiatric drugs abuse; 16. History of HIV infection; 17. Liver transplantation, this includes patients on a transplant list with the intention to transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to recurrence;overall survival;(Quality of Life; | — |
Countries
China
Contacts
Public ContactDecai Yu
Hepatobiliary Institute of Nanjing University
Outcome results
None listed