Eligibility |
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;
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