Hepatocellular Carcinoma
Conditions
Interventions
1:HAIC
2:TACE
Sponsors
Zhongshan hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with clinical or pathological diagnosis of hepatocellular carcinoma; 2. Patients with unresectable mid-term liver cancer exceeding the up to seven standard ("up to seven" refers to the maximum diameter of the tumor (CM) plus the number of tumors and the maximum is 7); 3. Patients without vascular invasion, lymph node and distant metastasis; 4. Patients with ECoG score 0; 5. Patients with child Pugh a liver function status; 6. Patients who have not received other anti-tumor therapy; 7. At least one patient with measurable target lesion in RECIST v1.1; 8. Patients whose life expectancy is at least 3 months; 9. Patients over 18 years old, regardless of gender. 10. Subjects with chronic hepatitis B virus (HBV) infection, HBV-DNA = 90 g / L (2) Neutrophil count >= 1.5 x 10^9 / L (3) Platelet count >= 75 x 10^9 / L (4) Total bilirubin concentration = 29 g / L (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 ml / min (9) Urinary protein = 2 +, 24-hour urinary protein < 1.0 g).
Exclusion criteria
Exclusion criteria: 1. Patients with cholangiocarcinoma or mixed cell carcinoma, combined with other tumors; 2. Patients with uncontrollable infection; 3. Treat patients with drug allergy history; 4. HIV infected patients; 5. Pregnant or lactating objects; 6. Patients with severe bleeding symptoms or clear gastrointestinal bleeding tendency in the first 30 days (those with fecal occult blood + + or above can not be included in the group). 7. Patients with grade II or above myocardial ischemia or infarction and poorly controlled arrhythmia (including QTc interval >= 450 ms for male and >= 470 MS for female) 8. According to NYHA standard, patients with grade III-IV cardiac insufficiency or left ventricular ejection fraction less than 50% examined by color Doppler ultrasound; 9. Patients with history of hepatic encephalopathy; 10. Patients with untreated active hepatitis (HBsAg positive and HBV-DNA >= 500 IU / ml; hepatitis C: HCV-RNA positive and liver function significantly abnormal; CO infection of hepatitis B and hepatitis C; hepatitis C: HCV-RNA positive and liver function significantly abnormal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free time; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;time to progression;objective regression rate;DCR;response rate of AFP; | — |
Countries
China
Contacts
Public ContactZhenggang Ren
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed