Hepatocellular carcinoma
Conditions
Interventions
Conversion therapy :Conversion therapy of atezolizumab combined with bevacizumab
Conversion therapy group:Surgery
Sponsors
General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent and able to comply with the visits and related procedures specified in the protocol. 2. Age>=18 years old and =12 weeks. 10. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period. 11. Have adequate organ and bone marrow function, and the laboratory test values within 7 days before enrollment meet the following requirements (no blood components, cell growth factors, albumin and other corrective drugs are allowed to be given within 14 days before obtaining laboratory tests), as follows: (1) Blood routine: absolute neutrophil count (ANC) >=1.5×10^9L; platelet count (PLT) >=50×10^9/L; Hemoglobin (HGB) >=8.5 g/dL. (2) Liver function: serum total bilirubin (TBIL) =28 g/L; alkalinephosphatase (ALP) =50mL/min (Cockcroft-Gault formula); The results of urinalysis showed that the urine protein was 2 . (4) Coagulation function: International normalized ratio (INR) <=2, and activated partial thromboplastin time (APTT) <=1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Contains fibroblastic layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, bile duct carcinoma and other components. 2. A history of hepatic encephalopathy or a history of liver transplantation. 3. Patients with hydrothorax, ascites and pericardial effusion with clinical symptoms or need drainage. 4. Acute or chronic active hepatitis b or c infection: HBV DNA>2000IU/ml or 104 /ml HCV RNA> 10^3 /ml HbsAg+ and HCVAb +. 5. Symptomatic central nervous metastasis. Patients with asymptomatic brain metastases or brain metastases whose symptoms are stable after treatment may participate in this study as long as they meet all the following criteriameasurable lesions outside the central nervous systemNo mesencephalon, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastasesRemain clinically stable for at least 4 weeksGlucocorticoid therapy was discontinued two weeks before the first dose of the study drug. 6. Varicose bleeding of esophageal or gastric fundus caused by portal hypertension has occurred in the past 6 months. 7. Any life-threatening bleeding event that has occurred within the previous 3 months, including the need for blood transfusion, surgery or topical treatment, and continued medication. 8. Previous history of vte events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep venous thrombosis, or any other serious thromboembolism, within 6 months. Except for those with stable thrombus after routine anticoagulant therapy, there are cases of catheter-derived thrombosis or superficial venous thrombosis. Preventive use of low dose aspirin and low molecular weight heparin is permitted. 9. Uncontrolled hypertension, systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg after optimal medical treatment, hypertensive crisis or hypertensive encephalopathy history. 10. Symptomatic congestive heart failure (New York heart association grade II-IV). Symptomatic or poorly controlled arrhythmias. QT interval was prolonged, QTc > 450ms(male), QTc > 470ms(female). 11. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic treatment. 12. A history of gastrointestinal perforations and/or fistulas, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months. 13. History of interstitial pneumonia, drug pneumonia, idiopathic pneumonia or active pneumonia. Radiation therapy is permitted in the area of radioactive pneumonia. 14. Active tuberculosis (TB), who are receiving anti-tb treatment or who received anti-tb treatment within 1 year prior to the first study. 15. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). 16. A severe infection that is active or clinically poorly controlled.Severe infections, including but not limited to hospitalization for infection, bacteremia, or complications of severe pneumonia, occurred 4 weeks before the first study. 17. Autoimmune disease requiring systematic treatment or a history of the disease within 2 years. A history of primary immunodeficiency is known. Patients with only positive autoantibodies will be asked to confirm the presence of autoimmune disease at the discretion of the investi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRFS(The patient who was successfully converted and received sequential surgical treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| conversion rate;objective response rate, ORR;Progression-Free Survival, PFS;Overall Survival, OS;pathological response rate;R0 resection rate; | — |
Countries
China
Contacts
Public ContactShichuan Lu
General Hospital of the Chinese People's Liberation Army
Outcome results
None listed