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Patients volunteered to participate in this study and signed informed consent |
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Age 18-75, male or female |
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ECOG PS score 0-1 |
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Child-pugh liver function grading: Grade A |
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The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition |
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According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors |
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b: 2-3 tumors with the maximum diameter ≤3cm; IIa: tumor 2-3,biggest > 3 cm in diameter |
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According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI |
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scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node |
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lesions, and the lesion has not received radiotherapy, freezing or other local |
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treatments) |
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Expected survival ≥ 6 months |
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The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) |
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Blood routine |
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Neutrophils ≥1.5×109//L Platelet count ≥100×109/L Hemoglobin ≥90g/L |
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Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value |
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(ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL)≤ |
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5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 2.5 times the upper |
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limit of normal value (ULN); Urine protein <2+;If urinary protein ≥2+,24-hour quantitative |
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urine protein must be ≤1g |
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Normal coagulation function, no active bleeding and thrombotic disease A |
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International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time |
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APTT≤1.5×ULN; C. Prothrombin time PT≤1.5ULN |
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Women of childbearing age should agree to use contraceptives (such as intrauterine |
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devices, contraceptives or condoms) during and within six months of the end of |
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medication; Patients with negative serum or urine pregnancy tests within 7 days prior |
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to study inclusion and who must be non-lactating, and males should agree to use |
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contraceptives during the study period and for 6 months after the end of the study |
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period |
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Subjects have good compliance and cooperate with the follow-up |
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Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other
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targeted therapies before
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Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell
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carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within
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years or concurrently
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Having hypertension that cannot be well controlled by antihypertensive drug therapy
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(systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous
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history of hypertension crisis or hypertensive encephalopathy
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Subject has previous or concurrent malignancies (except cured basal cell carcinoma of
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skin and carcinoma in situ of the cervix)
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Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be
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enrolled; Subjects are known to have prior allergies to macromolecular protein
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reparations or to any Tislelizumab or Lenvatinib excipients
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Subject has any active autoimmune disease or history of autoimmune disease (such as
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but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis
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hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism
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hypothyroidism; Subjects with vitiligo or childhood asthma have been completely
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relieved and may be included as adults without any intervention; Asthma requiring
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medical intervention with bronchodilators will not be included)
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Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone
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therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic
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hormones) and continue to receive such therapy within 2 weeks prior to enrollment
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Ascites or pleural effusion with clinical symptoms require therapeutic puncture or
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drainage
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Clinical symptoms or diseases of the heart that are not well controlled, such as
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NYHA2 or above heart failure Unstable angina pectoris Myocardial infarction occurred within
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year
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Patients with clinically significant supraventricular or ventricular arrhythmia
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requiring treatment or intervention
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The patient currently (within 3 months) has gastrointestinal diseases such as
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esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal
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hypertension, or active bleeding in unresected tumors, or other conditions determined
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by the researchers that may cause gastrointestinal bleeding or perforation
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Past or present severe bleeding (>30 ml bleeding within 3 months), hemoptysis (>5 ml
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fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or
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tia) within 12 months
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Subject has active infection or unexplained fever of >38.5 degrees during screening
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and before first administration (subject's fever due to tumor can be enrolled
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according to the investigator's judgment)
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Patients with past or present objective evidence of pulmonary fibrosis, interstitial
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pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe
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impairment of lung function, etc
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Subjects with congenital or acquired immune deficiency, such as HIV infection, or
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active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B
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reference: HBV DNA≥1000/ml; Hepatitis C reference: HCV RNA≥103/ml);Chronic hepatitis B
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virus carriers, HBV DNA < 1000 IU/ml, must receive antiviral treatment at the same
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time during the test can be enrolled
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Live vaccine is administered less than 4 weeks before or possibly during the study
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period
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The subject has a known history of psychotropic substance abuse, alcohol abuse or drug
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abuse
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The subject cannot or does not agree to bear the cost of the self-funded portion of
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the examination and treatment, except for the clinical study drug, combined
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chemotherapy and SAE related to the clinical study drug combined chemotherapy
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Researchers think that should be left out in this study, the researchers determine
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for example, the subjects have other factors that may result in this study were forced
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to midway termination, such as, other serious disease (including mental illness) need
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to merge treatment, there are serious abnormal laboratory examination, accompanied by
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factors such as family or society, will affect the safety of the subjects, or
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information and the collection of the sample
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