advanced liver cancer
Conditions
Interventions
Test group:ATRA+FOLFOX4
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1). Patients voluntarily joined the study and signed informed consent; 2). Between the ages of 18 and 75, regardless of gender; 3) Clinically or pathologically diagnosed hepatocellular carcinoma accompanied by at least one non-locally treated extrahepatic metastatic lesion (such as lung, abdominal cavity, bone, etc.) that can be measured (according to RECIST v1.1 requirements, spiral CT scan diameter of the measurable lesion =1.0cm or enlarged lymph node =1.5cm); And after first-line treatment failed; 4). Liver function Child A level; 5). Can swallow tablets normally, ECOG score: 0-1 6). Expected survival =12 weeks 7) Vital organ function complex with the following requirements (no blood components (such as albumin), cell growth factors and other corrective drugs can be used within 14 days before the first medication) : ? Hemoglobin =90g/L ? neutrophil count =1.5×109/L ? Platelet count =60×109/L ? Serum albumin =30g/l ? Total bilirubin =1.5*ULN (7 days before first dose) ? ALT and AST=3*ULN (7 days before first dose) ? AKP=2.5 x ULN ? Serum creatinine =1.5*ULN 8) Hepatitis B infection status: HBV-DNA1000 copies/ml, oral antiviral drugs should be started at least 1 week before chemotherapy. 9). Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of treatment; Women of reproductive age who were not surgically sterilized had to be negative for serum or urine HCG within 72 hours prior to study entry; And must be non-lactating.
Exclusion criteria
Exclusion criteria: 1). Patients with liver cancer who have previously received FOLFOX4 regimen; 2) Patients with liver tumor load greater than 50% of total liver volume, and central nervous system metastases; 3) Patients with ascites with clinical symptoms requiring puncture, continuous drainage, or who have received ascites drainage in the past 3 months, except those who only have a small amount of ascites shown by imaging without clinical symptoms; 4) Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of grade 2 or above, unstable angina pectoris; (2) Myocardial infarction occurred within 1 year; (3) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5) Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin, etc.; 6). Clinically significant bleeding symptoms or definite bleeding tendency have occurred within 3 months before randomization, such as gastrointestinal bleeding, varicose veins in the esophagus and gastric fundus with bleeding risk, hemorrhagic gastric ulcer or vasculitis, etc. In the baseline period, if the stool is positive for occultic blood, gastroscopy and colonoscopy should be performed. If the gastroscopy showed severe esophageal and gastric varices with red sign, they could not be included in the group. 7) Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 8). Urine routine indicated urinary protein =++ and 24-hour urinary protein volume was confirmed to be >1.0g; 9). Patients who had previously received radiation therapy, TACE, or hormone therapy, and who were less than 4 weeks prior to the study after the completion of treatment (last dose); Co-use of molecular targeted drugs is not affected, but should be avoided. Patients whose previous treatment-related adverse events (except alopecia) did not recover to =CTCAE grade 1; 10). The patient had an active infection, unexplained fever =38.5 ° C within 7 days prior to medication, or white blood cell count =15*10^9/l at baseline; 11). HCV, HIV or syphilis infection; 12). Patients with other malignant tumors within 3 years or at the same time; 13). Patients who suffer from headache or migraine for a long time and cannot be relieved by medication; 14) Researchers believe that other reasons should not participate in this study, such as serious mental illness, drug abuse, family or social factors should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Liver function;objective response rate; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed