Hepatocellular carcinoma
Conditions
Interventions
Locally advanced or metastatic HCC patients with disease progression after surgical resection or local treatment:medication
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who signed the written informed consent before the implementation of any trial related process; 2. Male or female >= 18 years old; 3. Subjects with ECoG PS score of 0-2; 4. Barcelona clinical liver cancer (BCLC) patients are classified as stage C and stage B which is not suitable for radical surgery and / or local treatment; 5. Subjects with child Pugh grade A or B; 6. Subjects with expected survival time > 3 months; 7. Patients with at least one measurable lesion according to recist1.1; 8. Subjects with total triiodothyronine (T3) or free T3 and free thyroxine (T4) in normal range (It can be controlled by thyroid replacement therapy). Asymptomatic subjects with abnormal T3, free T3 or free T4 were selected; 9. Subjects with adequate blood pressure control; 10. For sufficient organ function, subjects should meet the following laboratory indexes: (1) The absolute neutrophil count (ANC) >= 1.5x10^9/l in the past 14 days without using granulocyte colony-stimulating factor. (2) In the past 14 days without blood transfusion, the platelet count was more than 100 x 10^9/L; (3) Hemoglobin > 9g / dL in the past 14 days without blood transfusion or erythropoietin use; (4) Total bilirubin = 60 ml / min; (7) Good coagulation function was defined as INR or PT = 12 weeks; 13. The genetic test shows that people are sensitive to bevacizumab.
Exclusion criteria
Exclusion criteria: Subjects cannot have any of the following exclusion criteria: 1. Patients with fibrolamellar hepatocellular carcinoma and sarcomatoid hepatocellular carcinoma previously confirmed by histology / cytology; 2. Patients with history of hepatic encephalopathy or liver transplantation; 3. Patients with pleural effusion, ascites and pericardial effusion that need drainage; 4. In patients with acute or chronic active hepatitis B or hepatitis C infection, HBV DNA > 2000 IU / ml or 104 copies / ml; HCV RNA > 103 copies / ml; HBsAg and anti HCV antibody were positive at the same time; 5. Patients with central nervous system metastasis; 6. Patients with esophageal or gastric varices bleeding events caused by portal hypertension in the past 6 months. Severe (G3) varicose veins were found on endoscopy 3 months before the first administration. Patients with evidence of portal hypertension (including splenomegaly on imaging) and high risk of bleeding as assessed by the researchers; 7. Patients with any life-threatening bleeding events in the past 3 months, including patients requiring blood transfusion, surgery or local treatment, and continuous drug treatment; 8. Patients with previous arteriovenous thromboembolism events within 6 months, including history of myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, with the exception of patients with stable thrombosis after conventional anticoagulant therapy. Prophylactic use of low-dose LMWH (e.g. enoxaparin 40 mg / day) is permitted. 9. Subjects who used aspirin (> 325 mg / day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks before the first administration; 10. Patients with symptomatic congestive heart failure (NYHA II-IV). Symptomatic or poorly controlled arrhythmias. The corrected QTc of congenital long QT syndrome was more than 500ms (calculated by fridericia method); 11. Patients with severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy; 12. Subjects with a history of gastrointestinal perforation and / or fistula within 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial or extensive intestinal resection, complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea; 13. Patients who received radiotherapy three weeks before the first administration must meet all the following conditions before they can be enrolled: at present, there is no toxic reaction related to radiotherapy, glucocorticoid is not required, radiation pneumonia, radiation hepatitis, radiation enteritis, etc. are excluded; 14. Patients with previous and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases; 15. Patients with active pulmonary tuberculosis (TB), who are receiving antituberculosis treatment or who have received antituberculosis treatment within one year before the first administration; 16. HIV infected patients (HIV 1 / 2 antibody positive), known syphilis infected patients; 17. Patients with severe infection in active stage or poor clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective remission rate;Sustained remission rate;progression-free survival;safety; | — |
Countries
China
Contacts
Public ContactJian Li
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed