Hepatocellular carcinoma
Conditions
Interventions
Experimental group:PD1+ bevacizumab +HIFU
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma confirmed histologically/cytologically, or meets the clinical diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019); 2. Aged >= 18 years; 3. Barcelona Clinic Liver Cancer (BCLC) was divided into stages A, B and B; 4. The planned treatment regimen was cindilizumab combined with bevacizumab biosimilar drug; 5. At least 1 measurable or assessable lesion according to RECIST v1.1; 6. Expected survival >=12 weeks; 7. 0-2 points according to ECOG PS score of the Eastern United States Cooperative Oncology Group; 8. The Child - Pugh, 7 or less; 9. Expected survival time > 3 months; 10. At least 1 measurable lesion according to RECIST1.1 criteria; 11. Keep your blood pressure under control; 12. Sufficient organ function, subject should meet the following laboratory criteria: 13. The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L in the last 14 days without the use of granulocyte colony-stimulating factor; 14. Platelets >=100x10^9/L in the case of no blood transfusion in the last 14 days; 15. Hemoglobin >9g/dL in the absence of blood transfusion or use of erythropoietin in the last 14 days; 16. Total bilirubin = 60 mL /min; 19. Good coagulation function, defined as INR or prothrombin time (PT) = 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Previous histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc; 2. Have a history of hepatic encephalopathy or a history of liver transplantation; 3. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 4. Patients with acute or chronic active hepatitis B or C, hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen (HBsAg) and anti-HCV antibody were both positive; 5. There is central nervous system metastasis; 6. In the past 6 months, there was hemorrhage event of esophageal or fundus varices caused by portal hypertension. Severe (G3) varicose veins were known to be present on endoscopic examination within 3 months prior to initial administration. Evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator; 7. Any life-threatening bleeding event occurred within the previous 3 months, including the need for blood transfusion, surgery or local treatment, and continuous medication; 8. Previous events of thromboembolism, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep venous thrombosis, or any other serious thromboembolism in the past 6 months. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except in cases where the thrombosis is stable after conventional anticoagulant therapy. Allow prophylactic use of low dose and low molecular weight heparin (e.g., enoxaparin 40 mg/ day); 9. Use aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to initial administration; 10. Uncontrolled hypertension, after optimal medical treatment, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg, hypertensive crisis or history of hypertensive encephalopathy; Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or QTC > 500ms corrected at screening (calculated using the Fridericia method); 12. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy; 13. A history of gastrointestinal perforation and/or fistula within the previous 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; 14. Radiation therapy was received within 3 weeks prior to initial administration. Patients who received radiotherapy 3 weeks before their first dosing were eligible for inclusion only if they met all the following criteria: no current radiation-related toxicity, no need to take glucocorticoids, radiation pneumonia, radiation hepatitis, and radiation enteritis were excluded; 15. Previous and present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other pulmonary diseases; 16. People with active tuberculosis (TB), who are receiving anti-TB treatment or have received anti-TB treatment within 1 ye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard for evaluation of therapeutic efficacy of immunotherapy; | — |
Countries
China
Contacts
Public ContactZhu Hui
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed