medium-advanced Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of unresectable Hepatocellular Carcinoma; 2. BCLC Staging as B / C period; 3. Child-pugh liver function Rating: A level, B level (= score 7); 4. Aged=18 years; 5. ECOG (Eastern Cooperative Oncology Group) 0~2; 6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/L; PLT>50×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis:<5×ULN), and CR=1.25 ×ULN; 7. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Patients are preparing for liver transplantation (excepting those who have had previous liver transplantation). 3. Uncontrollable ascites, hepatic encephalopathy or bleeding of esophageal and gastric fundus varices; Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms) and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%); Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 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. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before screening; 9. Patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment; 10. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 11. Pregnant and lactating women; 12. Patients infected with union HIV; 13. Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year survival rate;ORR;DCR; | — |
Countries
China
Contacts
Public ContactJunhui Sun
The First Affiliated Hospital Zhejiang University
Outcome results
None listed