A Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation

Inclusion Criteria:

• Patients voluntarily join this study and sign informed consent form;

• Age≥18 years, male or female;

• Patients were diagnosed with hepatocellular carcinoma by histology or pathology orclinical diagnostic criteria for hepatocellular carcinoma in the "Guidelines for theDiagnosis and Treatment of Primary Liver Cancer (2024 Edition)", and have undergoneradical resection or ablation for hepatocellular carcinoma;

• No macrovascular invasion (allowing intraoperative or postoperative pathologicfindings of Vp1/Vp2 type portal vein invasion) or extrahepatic metastases assessedby imaging prior to radical treatment;

• Have high-risk recurrence risk factors, the assessment of which should be based onpre-procedure/ablation imaging;

• Child-Pugh liver function classification: Grade A;

• ECOG PS score: 0-1;

• Full recovery from surgical resection or ablation within 4 weeks prior toenrollment.

• Have not received anti-tumor treatment for hepatocellular carcinoma beforeenrollment, including systemic treatment and local treatment (except for 1-2 timesof prophylactic TACE or HAIC treatment 4-8 weeks after radical treatment);

• Patients who underwent radical therapy are allowed to receive 1-2 prophylacticTACE/HAIC treatments (as needed, not mandatory) 4-8 weeks postoperatively, and arerequired to have fully recovered from TACE/HAIC within 4 weeks prior to receivingstudy treatment;

• Patients infected with hepatitis B virus (HBV) who started anti-HBV treatment at thescreening stage and are willing to receive antiviral treatment (according to localguidelines, e.g., entecavir, etc.) throughout the study period and be monitoredregularly can be included; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positivepatients must receive antiviral treatment according to guidelines and have a liverfunction within the CTCAE grade 1 elevation;

• For female patients of childbearing potential and male patients whose partners arewomen of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use reliable and effective contraceptive methods for atleast 120 days from the time of signing the informed consent form until the lastdose of study drug.

• Adequate hematologic and organ function.

Exclusion Criteria:

• Known sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma andcholangiocarcinoma or fibrolamellar hepatocellular carcinoma;

• History of other malignant tumors within 5 years or simultaneously;

• Severe functional impairment of other vital organs such as heart, brain, lung andkidney;

• Immune deficiency or active autoimmune disease or history of autoimmune disease andthe disease may relapse;

• Evidence of tumor recurrence or metastasis before enrollment;

• History of hepatic encephalopathy;

• Known hypersensitivity to the active ingredients and excipients contained in theinvestigational drugs (camrelizumab, apatinib) of this study, or known history ofsevere allergy to any other monoclonal antibody or anti-angiogenesis targeted drug;

• Patients with active or history of interstitial pneumonitis or interstitial lungdisease requiring hormonal therapy, or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-induced pneumonitis, oridiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scanthat may interfere with the detection and management of immune-related pulmonarytoxicity; patients with severely impaired lung function; previous radiationpneumonitis in the radiation field is allowed; patients with active tuberculosis;

• Cardiac clinical symptom or cardiovascular disease that is not well controlled;

• History of gastrointestinal hemorrhage or clear tendency of gastrointestinalhaemorrhage within 6 months prior to the start of study treatment;

• Severe infection within 4 weeks prior to the start of study treatment; therapeuticantibiotics given orally or intravenously within 2 weeks prior to the start of studytreatment;

• Immunosuppressive or systemic hormone therapy for immunosuppression (dose >10 mg/dayprednisone or other equipotent hormone) within 14 days prior to the start of studytreatment;

• Patients who are preparing for or have previously received an organ or allogeneicbone marrow transplantation;

• Subjects with hypertension that is not well controlled or history of hypertensivecrisis or hypertensive encephalopathy;

• Significant vascular disease (eg, aortic aneurysm requiring surgical repair orrecent peripheral arterial thrombosis) within 6 months prior to the start of studytreatment; ular heparin is permitted)

• Known genetic or acquired hemorrhage (e.g., coagulation disorders) or thrombotictendency, such as hemophiliacs; current or recent (within 10 days prior to start ofstudy treatment) use of full-dose oral or injectable anticoagulant or thrombolyticmedications for therapeutic purposes (prophylactic use of low-dose aspirin,low-molecular heparin is permitted)

• Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6months prior to the start of study treatment;

• History of intestinal obstruction and or history of clinical signs or symptoms ofgastrointestinal obstruction;

• Thrombosis or thromboembolic event within 6 months prior to the start of studytreatment, such as cerebrovascular accident (including transient ischemic attack,cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.

• Treatment with a live attenuated vaccine within 28 days prior to the start of studytreatment or anticipation of need for such a vaccine during treatment withcamrelizumab or within 60 days of the final dose of camrelizumab;

• Pregnant or breastfeeding patients;

• Patients who, in the judgment of the investigator, have other factors that mayaffect the results of the study or cause forced termination of this study, such asalcoholism, drug abuse, other serious illnesses (including psychiatric illnesses)that require comorbid treatment, and serious laboratory abnormalities accompanied byfamilial or social factors, which would affect the safety of the patient.