GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

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• Main Inclusion Criteria:
• Voluntarily participates in the study and provides written informed consent.
• Male or female, age ≥ 18 and ≤ 80 years old
• Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.
• Has CNLC stage II to IIIa disease.
• Has at least one measurable lesion according to mRECIST.
• Child-Pugh class A or B.
• ECOG performance status of 0 - 2.
• Adequate hematologic and organ function.
  • Main Exclusion Criteria:
• Has a known allergy to the investigational product or related components, including human serum albumin and IL-2.
• Has another incurable malignancy within 5 years before screening or concurrently.
• Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
• Has received therapy aim to target lesion(s) within 12 weeks before screening.
• 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.
• Has other active disease.