HAIC Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients With High Risk of Recurrence After Resection

Inclusion Criteria:

1. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1;
2. The expected survival is more than 3 months;
3. Histologically or cytologically diagnosed as HCC;
4. After hepatectomy, satisfy any of the following recurrence factors: a) microvascular invasion (MVI); b) Single tumor diameter ≥ 8cm; c) The tumor grew infiltratively, unclear boundary and no complete capsule; d) Multiple tumor nodules ≥3, or nodules\<3 but the diameter of a single tumor is \> 3cm; e) With portal vein, hepatic vein or cholangiocarcinoma thrombus; f) tumor ruptured or invaded adjacent organs before surgery.
5. hepatitis B virus (HBV) DNA\<2000IU/mL;
6. Liver function status Child-Pugh grade A (≤6);
7. The main organs function well.
8. Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥8.0 g/L, Neutrophils (ANC) ≥ 1.5×10\^9/L, Platelet count (PLT) ≥ 60×10\^9/L, Total bilirubin (TBIL) ≤3.0 mg/dL, albumin≥28 g/L, Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase≤ 5.0 ×upper limit of normal, International Prothrombin Standardization Ratio (INR) ≤ 2.3, Thyroid-stimulating hormone (TSH) ≤upper limit of normal;
9. The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
10. Voluntary participation and written informed consent;

Exclusion Criteria:

1. History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)
2. Other adjuvant therapy after surgery, such as targeted drugs, programmed death-1 (PD-1) antibody and other immunotherapy, FOLFOX systemic chemotherapy;
3. The imaging examination showed residual tumor after the surgical resection;
4. Patients with previous liver transplantation or preparation for liver transplantation.
5. Patients who are allergic to components of TQB2450 and anlotinib or pharmaceutical excipients;
6. Received any live attenuated vaccine within 4 weeks of admission or during the study period;
7. Patients with a history of immunodeficiency (or autoimmune disease), or other acquired congenital immunodeficiency diseases.
8. Hypertension which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).
9. A history of gastrointestinal bleeding within 3 months before enrollment;
10. A history of arterial and venous thrombotic events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
11. Hereditary or acquired hemorrhagic and thrombotic tendencies, such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.
12. Pts need to long-term anticoagulant therapy;
13. Participated in any other drug clinical studies within 3 months before enrollment;
14. A history of psychotropic substance abuse or drug abuse;
15. Patients with concomitant diseases which could seriously endanger their own safety or could affect the completion of the study according to investigators' judgment;