liver cancer
Conditions
Interventions
B:FOLFOX4
Sponsors
Eastern Hepatobiliary Surgical Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Male and female, ages 20-70 years; 3. Clinically or pathologically diagnosed hepatocellular carcinoma accompanied by at least one measurable metastatic lesion (such as lung, abdominal cavity, bone, etc.) that has not been treated ever before.The diameter of the lesion should >=1.0cm or the enlarged lymph node of 1.5cm according to RECIST v1.1; 4. Child-Pugh Class A or B; 5. ECOG performance status Grade 1 or less; 6. The expected survival was greater than 12 weeks; 7. The functions of vital organs meet the following requirements(No blood components, cytokines, or other corrective therapy should be used within 14 days before the first administration): Hemoglobin>=90 g/L; neutrophil count>=1.5*10^9/L; platelet count>=60*10^9/L; serum albumin>=30g/l; Total bilirubin1000 copies/ml, oral antiviral drugs should be recommended at least 1 week before chemotherapy; 9. For non-surgical sterilization or reproductive age of female patients, a medically approved method of contraception is required during the study and within 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1.HCC patients who had been treated with the FOLFOX4 regimen; 2.Liver tumor burden was greater than 50% of the total liver volume, and with defined brain metastases; 3.Ascites with clinical symptoms requiring puncture, continuous drainage, or receiving ascites drainage for the past 3 months, except for those who showed a small amount of ascites by imaging,but without linicalptoms; 4.Have heart clinical symptoms or disease that are not well controlled:(1) heart failure above grade 2, unstable angina pectoris; (2) myocardial infarction occurred within 1 year; (3) supraventricular or ventricular arrhythmia needs treatment or intervention; 5. Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or being treated with thrombolysis or anticoagulation, allowing preventive use of low-dose aspirin, low molecular heparin, etc; 6.Bleeding symptoms with significant clinical significance or a clear tendency to bleeding were observed within 3 months; 7.Known hereditary or acquired bleeding and tendency to thrombosis such as hemophilia patients, coagulopathy, thrombocytopenia and so on; 8.Urinary routine suggested that urinary protein was greater than ++ and 24-hour urinary protein was confirmed to be>1.0g. 9.Patients who had received radiotherapy, TACE, and hormone therapy within 4 weeks; 10.Patients with active infection; 11.patients with HIV, HCV or syphilis; 12.The patient had other malignant tumors within the previous 3 years or at the same time; 13.Patients with chronic headaches or migraines who cannot be relieved by medication; 14.Other reasons were not considered appropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DoR;TTR;DCR;ORR; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
Eastern Hepatobiliary Surgical Hospital
Outcome results
None listed