Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies

Inclusion Criteria:

1. Age ≥18 years old, ≤75 years old, gender unlimited;

2. primary hepatocellular carcinoma proved pathologically and clinically;

3. 2 months after radical resection or ablation, imaging examination (MRI, CT plainenhanced) showed no tumor lesions, HCC recurred within 3 years after surgery, noextrahepatic metastasis;

4. ECOG score 0-1;

5. Recurrent liver cancer meets the Milan criteria: single tumor diameter ≤5cm ormultiple tumors less than 3 with a maximum diameter ≤3cm, no major vascularinvasion, no lymph node metastasis or extrahepatic metastasis;

6. Child-Pugh liver function grades: A, B;

7. Expected survival > 6 months;

8. Adequate organ function: ① no need for growth factors and blood components within 2weeks prior to enrollment; (2) Cardiac function: no heart disease, coronary heartdisease, cardiac function level 1-2; ③ In the first 7 days of enrollment, liver andkidney function was adequate and laboratory indicators were suitable (untreated) :HGB≧9.0g/dl, neutrophils ≧1,500/mm3, PLT≧50x109/L, serum ALB≧28g/L, TBIL<2mg /dL,ALT, AST< 5 times of the upper limit of normal value, Bun, Cr< 1.5 times of theupper limit of normal value, INR<1.7 or extended PT<3s;

9. Patients with normal blood pressure or hypertension should use antihypertensivedrugs to control blood pressure within the normal range;

10. Diabetic patients should control fasting blood glucose ≤8mmol/L by hypoglycemicdrugs;

11. No other serious diseases (such as autoimmune diseases, immune deficiency, organtransplantation, etc.) that conflict with the Plan;

12. No history of other malignant tumors;

13. Women of childbearing age must have a negative blood pregnancy test within sevendays, and subjects of childbearing age must use appropriate contraception during thetest and for six months after the test;

14. The patient agrees to participate in the clinical study and sign the InformedConsent.

Exclusion Criteria:

• (1) previous radiotherapy, hormone therapy or molecular targeted therapy; (2)Patients with distant metastasis confirmed by imaging; (3) The subject has had orco-has other malignancies (other than cured basal cell carcinoma of the skin andcarcinoma in situ of the cervix); (4) The subject is known to be allergic tomacromolecular protein preparations, or to any component of anti-PD-1 antibodies; (5) Subject has any history of active autoimmune disease or autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism,hypothyroidism; Subjects with childhood leukoplectic disease or complete remissionof asthma can be incorporated into adults without any intervention; Subjectsrequiring medical intervention with bronchodilators are not included; (6) Subjectswere taking immunosuppressants, or systemic or absorbable topical hormone therapyfor immunosuppressive purposes (doses >10mg/ day of prednisone or other therapeutichormones) and were still taking them within 2 weeks prior to enrollment; (7)Clinical symptoms of heart disease or disease not well controlled, such as: heartfailure of grade 2 or above A.N. B. Unstable angina pectoris; C. Myocardialinfarction within 1 year; D. Patients with clinically significant supraventricularor ventricular arrhythmias requiring treatment or intervention; (8) Abnormalcoagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendency orreceiving thrombolytic or anticoagulant therapy; (9) The patient has current (within 3 months) gastrointestinal conditions such as esophageal varices, active gastric andduodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding fromunexcised tumors, or other conditions identified by the investigator as likely tocause gastrointestinal bleeding and perforation; (10) Previous or current severebleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4weeks), or thromboembolic events (including stroke events and/or transient braindysfunction) within 12 months; (11) Previous and current patients with objectiveevidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiationpneumonia, drug-induced pneumonia, severe impairment of lung function, etc.; (12) ofcongenital or acquired immune deficiency, such as HIV infection, active hepatitis (transaminase does not meet the criteria for the hepatitis b reference: HBV DNA of 10 or higher ⁴ / ml; Hepatitis C reference: HCV RNA≥103/ml); Chronic hepatitis Bvirus carriers with HBV DNA<2000 IU/ml (<104 copies /ml) must also receive antiviraltherapy during the trial to be enrolled; (13) Subjects are participating in otherclinical studies or less than one month has passed since the end of the previousclinical study; Subjects may receive other systemic antitumor therapies during thestudy; (14) The subject is known to have a history of psychotropic, alcohol, or drugabuse; (15) Imaging examination confirmed tumor recurrence or metastasis 2 monthsafter surgery; (16) The researcher believes that it should be excluded from thisstudy. For example, in the researchers' judgment, the subjects had other factorsthat might have led to the study's termination, such as other serious medicalconditions (including mental illness) requiring combination treatment. Seriouslaboratory abnormalities, accompanied by family or social factors, may affect thesafety of the subject or the collection of data and samples.