A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma

This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.

Inclusion Criteria: * Voluntarily participates in the study and provides written informed consent. * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has not received transarterial chemoembolization within 6 months before screening. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening. Exclusion Criteria: * Has a known allergy to the investigational product or related components, including human serum albumin. * Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has major vascular invasion on imaging. * Has hepatic encephalopathy within 4 weeks before screening. * Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage within 2 weeks before enrollment.