An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of Adebrelimab Plus Apatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection
This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.
‣ Participants must meet all of the following conditions in order to be enrolled in this study:
• Voluntarily participate in this study and sign an informed consent form.
• Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).
• Within 4-12 weeks prior to enrollment, radical resection surgery was performed.
• Complete recovery from surgical resection within 4 weeks prior to enrollment.
• High risk factors for postoperative recurrence of hepatocellular carcinoma include multiple tumors, tumor length\>5 cm, poor tumor differentiation (Edmondson III-IV grade), margin ≤ 1 cm, invasion of Microvasculature or large vessels, lymph node metastasis, sustained abnormalities in AFP or abnormal prothrombin , etc.
• Child Pugh liver function rating within 7 days prior to randomization: A or B (≤ 7 points).
• ECOG PS score within 7 days before randomization: 0-1 points.
• Have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past.
• Expected survival time ≥ 12 weeks.
⁃ The main organ functions meet the following requirements (within 7 days before randomization):
‣ (1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor \[G-CSF\], no medication correction):
‣ • Neutrophil absolute count ≥ 1.5 × 109/L; Platelets ≥ 75 × 10\^9/L; • Hemoglobin ≥ 90 g/L.(Leukocyte and thrombocytopenia caused by splenic hyperfunction can be included in the group after partial embolization of the splenic artery or medication correction) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin ≥ 28g/L; Total serum bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; Blood creatinine ≤ 1.5 x ULN or Cr clearance rate\>50ml/min (3) International standardized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the range of normal control ≤ 6 (4) Urinary protein\<2+(If urinary protein ≥ 2+, 24-hour urine protein quantification is required, and 24-hour urine protein quantification\<1.0g can be included in the group).
‣ 11\. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor it; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to the diagnosis and treatment guidelines, and their liver function must be within CTCAE1 level elevation.
• Women with fertility: must agree to contraception from the signing of the informed consent form until 90 days after the last use of the study drug (whichever is longer). And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactation period