hepatocellular carcinoma
Conditions
Interventions
Group A:TACE+sintilimab+Bevacizumab
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to the implementation of any test related procedures, sign written informed consent. 2. No gender limit, aged >=18 years. 3. The score of ECOG PS is 0-1. 4. The patient was initially diagnosed with HCC according to the diagnostic criteria of the Chinese Standards for Primary Liver Cancer Diagnosis and Treatment (2019 Edition). 5. Barcelona Clinic Liver Cancer (BCLC) is stage A and stage B not suitable for radical surgery and/or local treatment. 6. Had not received systemic antitumor therapy for hepatocellular carcinoma in the past (patients were allowed to be enrolled more than 6 months after the end of postoperative adjuvant chemotherapy). 7. Child-Pugh grade A. 8. Expected survival time >3 months. 9. At least 1 measurable lesion according to RECIST1.1 criteria. 10. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) were within normal ranges. (It can be controlled with thyroid replacement therapy). Patients with asymptomatic T3, free T3, or abnormal T4 may be enrolled. 11. Get your blood pressure under control. 12. Have adequate organ and bone marrow function, and laboratory test values within 7 days prior to randomization meet the following requirements (which are not allowed to be met by administration of any blood component, cell growth factor, albumin, or other corrective therapy drugs within 14 days prior to receipt of laboratory test), as follows: (1) Blood routine: absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=75x10^9/L; Hemoglobin content (hemoglobin, HGB) >= 9.0g /dL; (2) Liver function: serum total bilirubin (TBIL) =28 g/L; (3) Kidney function: serum creatinine (Cr) = 50mL/min (Cockcroft-Gault formula); Urine routine results showed that urine protein =2+ in routine urine test at baseline, 24-hour urine collection and 24-hour protein quantity <1g should be performed; (4) Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2. Have a history of hepatic encephalopathy or liver transplantation; 3. History of kidney disease or nephritis syndrome; 4. Pleural fluid, ascites, pericardial effusion with clinical symptoms requiring drainage; 5. Patients with acute or chronic active hepatitis B or hepatitis 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 positive; 6. Central nervous system metastasis; 7. Bleeding events of esophageal or fundus varices caused by portal hypertension have occurred in the past 6 months. Severe (G3) varicose veins were known on endoscopy within 3 months prior to initial administration. Evidence of portal hypertension (including splenomegaly on imaging), high risk of bleeding as assessed by the investigator, and high risk of gastrointestinal bleeding; 8. Any life-threatening bleeding event, including the need for transfusion therapy, surgical or local treatment, ongoing medication, has occurred within the previous 3 months; 9. History of arteriovenous thromboembolism events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, except in patients with stable thrombus after conventional anticoagulant therapy. Allow prophylactic use of low-dose low-molecular heparin (e.g. Enoxaparin 40 mg/ day); 10. A history of PV3/PV4 cancer thrombus in the main portal vein; 11. Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 12. Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10mg/ day of prednisone or equivalent doses of other corticosteroids), temporary use of corticosteroids for the treatment of symptoms of breathing difficulties in asthma, chronic obstructive pulmonary disease, etc.; 13. Receive live attenuated vaccine within 4 weeks prior to initial administration or during the planned study period; 14. Prior receipt of any anti-PD-1 antibody, anti-PD-L1 /L2 antibody, anti-CTLA4 antibody, or other immunotherapy. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival at 6 months and 1 year;Overall survival, OS;Overall survival at 6 months and 1 year ;Disease control rate, DOR; | — |
Countries
China
Contacts
Public ContactDong Liyang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed