hepatocellular carcinoma
Conditions
Interventions
Case series:Case series
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged from 18-75 years. 2. ECOG Performance Status of 0-2. 3. The expected survival time = 3 months. 4. Histologically or cytologically confirmed diagnosis of Hepatocellular Carcinoma and have undergone R0 radical surgical resection, postoperative pathology indicated negative margin. 5. proven hepatocellular carcinoma with one or more high-risk recurrence factors, including ?MVI; ?the number of tumor=2; ?the diameter of primary tumor>5.0cm according imageological or pathological examination. 6. Child-Pugh class: A or B7. 7. BCLC Staging as B and C period. 8. HBV DNA<2000 IU/ml(or 104 copies/ml)or HCV RNA <103 copies /ml. 9. the lab test could meet: neutrophil count=1.5×10^9/L; hemoglobin=90g/L; platelet count=50×10^9/L; total bilirubin<2-times upper limit of normal; ALT<2.5-times upper limit of normal; AST<2.5-times upper limit of normal; serum creatine<1.5-times upper limit of normal. 10. Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Exclusion criteria
Exclusion criteria: 1. Recurrent HCC or subjects who have received neoadjuvant therapy; 2. Subjects with portal vein and its branches thrombus or other large blood vessel invasion; 3. Subjects with extrahepatic metastases; 4. Have received Topical treatment (including but not limited to TACE, radiotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 4 weeks prior to participation in the study; 5. Received prior systemic anti-cancer therapy for HCC; 6. Hepatic duct carcinomamixed cell carcinoma and fiberboard layer cell carcinoma which have confirmed; Past (5 years) or current with other malignant tumor, except skin basal cell carcinoma and cervical carcinoma in situ; 7. Liver transplantation, this includes patients on a transplant list with the intention to transplant; 8. Uncontrolled ascites and hepatic encephalopathy; 9. Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); 10. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms) and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy; 15. Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment; 16. Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g; 17. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives; 18. Subjects with mental illness or a history of psychotropic substance abuse; 19. HIV infection; 20. Other conditions that the investigators considered that not unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTR;1 year RFS rate;3 year RFS rate;OS; | — |
Countries
China
Contacts
Public ContactJun Yu
The First Affiliated Hospital Zhejiang University
Outcome results
None listed