A Study of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma

Exclusion Criteria

• •Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.
• •Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.
• •Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.
• •History of leptomeningeal or central-nervous-system metastases.
• •Neurologic disorder ≥ Grade 2 (CTCAE).
• •Having experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 3 months. Patients with evidence of portal hypertension and a high bleeding risk as assessed by the investigator.
• •Having experienced any life-threatening bleeding events within the past 3 months, including those requiring transfusion, surgery, local treatment, or continuous pharmacological therapy.
• •History of stroke or central nervous system hemorrhage; Prior stroke, CNS hemorrhage, TIA, or RIND within 6 months.
• •Uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg despite optimal therapy), hypertensive crisis, or hypertensive encephalopathy.
• •Symptomatic CHF (NYHA ClassII-IV), Symptomatic or poorly controlled arrhythmias. Electrocardiogram (ECG) showing clinically significant abnormalities, or QTc interval ≥ 450 milliseconds in men, ≥ 470 milliseconds in women (≥ 480 milliseconds for subjects with bundle branch block on consecutive ECGs) (calculated using Fridericia's formula).
• •Severe bleeding diathesis, coagulopathy, or ongoing thrombolytic therapy.
• •A history of or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, or severely impaired pulmonary function.
• •HBsAg-positive subjects with HBV-DNA above the lower limit of detection at the study site must receive at least 7 days of antiviral therapy before the first dose and are willing to continue antiviral treatment for hepatitis B as required during the study to be eligible for enrollment. HBsAg-negative but HBcAb-positive subjects with HBV-DNA below the lower limit of detection at the study site will be closely monitored for HBV-DNA and liver transaminase levels during the dosing period. If HBV reactivation occurs during the treatment period, these subjects must agree to immediately initiate antiviral therapy for hepatitis B to remain eligible. All such subjects must be willing to continue antiviral treatment for hepatitis B for at least 6 months after the last dose, and the investigator may follow up on hepatitis B markers based on individual patient circumstances. Active hepatitis C: HCV antibody-positive with HCV-RNA levels above the lower limit of detection at the study site; co-infection with hepatitis B and hepatitis C.
• •Active tuberculosis (TB), subjects currently receiving anti-TB treatment or those who have received anti-TB treatment within 1 year before the first dose.
• •HIV-positive or active syphilis.
• •Subjects with active or poorly controlled serious infections; those who have had severe infections within 4 weeks before peripheral blood collection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.
• •Active autoimmune disease requiring systemic therapy (immunosuppressants, corticosteroids, or DMARDs) within 2 years and not adequately controlled.
• •History of malignancy (other than HCC) within 5 years.
• •Known hypersensitivity to study drug or its components.
• •Pregnant or lactating women.
• •Subjects deemed unsuitable for participation in this trial by the investigator.