Hepatocellular carcinoma
Conditions
Interventions
control group:TACE in combination with Sindilizumab and bevacizumab:TACE+ Sindilizumab+Bevacizumab
test group:Partial hepatectomy:Partial hepatectomy
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate and sign a written informed consent; 2.Adult patients (Age 18-70), regardless of gender; 3. The ECOG PS score is 0-1; 4.The patient was clinically diagnosed with hepatocellular carcinoma; 5.The number of tumors is 2 or 3 and the maximum diameter of one tumor is more than 3cm, or the number of tumors is 4 or 5; 6.Tumors are technically resectable and there should be sufficient residual liver volume after hepatectomy. 7.No vascular invasion or extrahepatic metastasis; 8.Have not received systemic anti-tumor therapy for hepatocellular carcinoma; 9.Child-Pugh grade A; 10. Expected survival time >3 months; 11.At least 1 measurable lesion according to RECIST1.1 criteria; 12.Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal range. Subjects with asymptomatic T3, abnormal free T3, or free T4 could be enrolled; 13.Adequate control of blood pressure; 14.Have adequate organ and bone marrow function, and laboratory test values within 7 days prior to randomization meet the following requirements (the conditions are not allowed to be met by administering any blood component, cell growth factor, albumin, or other corrective therapy drugs within 14 days prior to obtaining the laboratory test), as follows: 1)absolute neutrophilcount (ANC) =1.5×109/L; platelet count (PLT) =75× 109 /L; hemoglobin content (hemoglobin, HGB) =9.0 g/dL; 2) Liver function: Serum total bilirubin (TBIL) =1.5× upper limit of normal value (ULN); Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), aspartate transferase (AST) and Alkaline phosphatase (ALP) =2×ULN; Serum albumin =28 g/L; 3) Renal function: serum creatinine (Cr) = 1.5×ULN;Clearance of creatinine (CCr) =50mL/min (Cockcroft-Gault formula); Urine routine results showed that urine protein <2+; For patients with urine protein =2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification <1g should be performed. 4) Coagulation function: internationalnormalized ratio (INR) and activated partial thromboplastin time (APTT) =1.5 times ULN; 15. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration). Expected survival =12 weeks.
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.There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion; 4. Acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4copies /ml; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive simultaneously. 5.Central nervous system metastasis; 6. Bleeding events of esophageal or gastric varices caused by portal hypertension occurred within the past 6 months. Severe (G3) varicose veins were known to be present on endoscopy within 3 months prior to first administration. Patients with evidence of portal hypertension (including splenomegaly on imaging) who are at high risk of bleeding as assessed by the investigator; 7.Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion treatment, surgery or local treatment, continuous medication; 8. 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 intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except in cases where the thrombus has stabilized after conventional anticoagulant therapy. Allow the prophylactic use of low-dose, low-molecular heparin (e.g., enoxaparin 40 mg/ day); 9.Use aspirin (> 325mg/ 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.Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 11.Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. A QTc > 500ms adjusted for congenital long QT syndrome history or screening (calculated using the Fridericia method); 12.Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy; 13.A previous history of gastrointestinal perforation and/or fistula within the last 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterectomy (partial colectomy or extensive enterectomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 14.Received radiation therapy within 3 weeks prior to the first dose. Patients who received radiation therapy three weeks before the first dose must meet all of the following criteria to be enrolled: there is no current toxic reaction associated with radiation therapy, no need to take glucocorticoids, and radiation pneumonia, radiation hepatitis, and radiation enteritis are excluded; 15.Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases; 16. People with active tuberculosis (TB) who are receiving anti-TB therapy or who have received anti-TB therapy w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Event-free survival;Recurrence-free survival;Objective remission rate; | — |
Countries
China
Contacts
Public ContactZHOU weiping
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed