Hepatocellular carcinoma
Conditions
Interventions
Experimental group1:cindilizumab
Experimental group2:bevacizumab
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Inoperable HCC, newly treated patients with type i-iv PVTT; 3. Child pugh Class A/B (<=7 points); 4. ECOG PS 0-2; 5. Quantitative hepatitis B DNA <500IU/ml; 6. At least one measurable lesion.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. Have a history of hepatic encephalopathy, or have a history of liver transplantation; 3. Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage; 4. There is central nervous system metastasis; 5. In the past 6 months, there has been an event of bleeding from esophageal or gastric varices caused by portal hypertension. Severe varicose veins were known to be present on endoscopy within 3 months before the first administration. Those with evidence of portal hypertension (including splenomegaly detected by imaging examination), who have been assessed by the investigator as having a high risk of bleeding; 6. Any life-threatening bleeding event occurred in the past 3 months, including the need for blood transfusion treatment, surgery or local treatment, and continuous drug treatment; 7. Arterial and venous thromboembolism events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except for those with stable thrombosis after conventional anticoagulation therapy. Allow preventive use of low-dose low-molecular-weight heparin (such as enoxaparin 40 mg/day); 8. Within 2 weeks before the first administration, use aspirin (> 325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days; 9. Uncontrollable hypertension, systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg after the best medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 10. Symptomatic congestive heart failure (New York Heart Association Grade ii-iv). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or QTc adjusted during screening>500ms (calculated by Fridericia method); 11. Severe bleeding tendency or coagulation dysfunction, or are receiving thrombolytic therapy; 12. History of gastrointestinal perforation and/or fistula in the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea; 13. Past and present history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases; 14. Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration; 15. people infected with immunodeficiency virus (HIV) (HIV 1/2 antibody positive), people with known syphilis infection; 16. Severe infections in active phase or poorly controlled clinically. Severe infection within 4 weeks before the first administration, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 17. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security;Objective response rate; | — |
Countries
China
Contacts
Public ContactLi Minghuan
Shandong Cancer Hospital
Outcome results
None listed