Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma

Inclusion Criteria:

1. Voluntarily join the study and sign the informed consent;

2. Age 18 ~ 80 years old (including 80 years old), male and female;

3. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed byhistology / cytology according to the code for diagnosis and treatment of primaryliver cancer (2022 Edition);

4. Hepatocellular carcinoma and technically resectable (CNLC stage Ⅱb to Ⅲa), estimatedresidual liver volume >30%, in patients with cirrhosis, the residual liver volume is >40%. And meets at least one of the following conditions:

5. The tumor is adjacent to large blood vessels or other organs, resulting in anexpected surgical margin of less than 1cm;

6. Cancer thrombus formation was associated with ipsilateral portal vein orhepatic vein, but the tumor thrombus did not accumulate in the maincontralateral portal vein, contralateral portal vein, contralateral hepaticvein, and superior mesenteric vein;

7. At least one assessable lesion (mRECIST criteria),and did not receive radiotherapyor local treatmen;

8. ECOG 0 ~ 1;

9. Major organs are functioning normally. Hemoglobin ≥ 90 g / L; ANC ≥ 1.5 × 109/L；Platelet count ≥ 100 × 109/L； Albumin ≥ 28 g / L; Total bilirubin ≤ 3 × ULN; AST,ALT ≤ 5 × ULN； TSH ≤ ULN； INR or PT ≤ 1.5 × ULN, APTT ≤ ULN.

10. If HBsAg (+) and/or anti-HCV (+), antiviral therapy should be standard based on HBVDNA or HCV RNA test results;

11. Be able to cooperate to observe adverse events. -

Exclusion Criteria:

1. Cholangiocarcinoma, mixed cell carcinoma and fibrous laminar cell carcinoma areknown

2. Diffuse tumor lesions

3. extrahepatic metastasis

4. Active malignancies other than HCC occur within 5 years or at the same time, withthe exception of cured skin basal cell carcinoma, cervical carcinoma in situ andthyroid form carcinoma;

5. Received radical hepatectomy, systemic anticancer therapy for liver cancer (mainlyincluding systemic chemotherapy, molecular targeted therapy, CTLA-4, PD-1/PD-L1monoclonal antibody immunotherapy) and local liver therapy, including TACE, HAIC,TAE, local ablation, radiotherapy, etc;

6. The following conditions were present during the course of the study: myocardialinfarction, severe unstable angina pectoris, NYHA2 or higher cardiac insufficiency,poor arrhythmia control, symptomatic congestive heart failure, cerebrovascularaccident;

7. A history of hypertensive crisis or hypertensive encephalopathy;

8. The subject has any history of active autoimmune disease or autoimmune disease (butnot limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Subjects with vitiligo or childhood asthma are in complete remission and can beincluded as adults without any intervention; Asthma requiring medical interventionwith bronchodilators will not be included);

9. Subjects are receiving immunosuppressive, systemic or absorbable local hormonetherapy for immunosuppressive purposes and continue to receive such therapy duringthe 2 weeks prior to enrollment;

10. Abnormal coagulation (INR > 1.5 or APTT > 1.5 x ULN) with bleeding tendency orreceiving thrombolysis or anticoagulation therapy;

11. Known severe adverse reactions to Donafenib, sindillizumab, or severe allergicreactions to other monoclonal antibodies;

12. The subject has a known history of psychotropic, alcohol, or drug abuse. -