Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence Factors

Exclusion Criteria17

• Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
• Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
• Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
• Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.
• History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Subjects with esophageal or gastric varices requiring intervention within 28 days before enrollment. Untreated or inadequately treated esophageal or gastric varices deemed by investigators to pose a high risk of bleeding.
• The subject is unable to undergo contrast-enhanced liver CT or MRI scans.
• Patients who do not meet the criteria for radical surgery.
• Received Chinese herbal medicine or Chinese patent medicine with antitumor indications or immunomodulatory drugs (including systemic use of thymosin, interferon, etc.) within 14 days prior to enrollment.
• Participation in other drug clinical trials within 4 weeks prior to enrollment.
• Co-infection with HBV and HCV (defined as HCV infection history with negative HCV RNA, which was considered as non-infection in this study).
• History of arterial or venous thromboembolic events occurring within 6 months prior to enrollment, including myocardial infarction (MI), unstable angina, cerebrovascular accident or transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), or any other severe thromboembolic event.
• Patients with cardiopulmonary insufficiency.
• Severe infection in the active phase or with poor clinical control. A severe infection within 4 weeks prior to the first treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.
• Known hypersensitivity to any investigational drug ingredients; or a history of severe allergic reactions to other traditional Chinese patent medicines.
• Known history of drug abuse, alcoholism, or substance use.
• Individuals with a history of psychiatric disorders and lacking capacity for conduct or having limited capacity for conduct.
• Other acute or chronic diseases, mental disorders, or abnormal laboratory test results that may lead to the following outcomes: increased risks for the subject to participate in the study or receive study treatment, interference with the interpretation of study results, or, at the investigator's discretion, that participation in the study is not in the subject's best interest.