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with TACE according to the study protocol.",[13,14],"Drug: GKL-006 Injection","Procedure: TACE",{"label":16,"type":17,"description":18,"interventionNames":19},"TACE alone","ACTIVE_COMPARATOR","Participants will receive transarterial chemoembolization (TACE) alone according to the study protocol.",[14],[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","GKL-006 Injection","An iNKT cell therapy",[9],[27,28],"GKL-006","iNKT cells",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","TACE","A standard locoregional therapy for hepatocellular carcinoma",[9,16],null,[36],{"name":37,"affiliation":38,"role":39},"Gaojun Teng, MD","Zhongda Hospital, South University","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":34,"email":45},"Zhongda 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Carcinoma","A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma","Main Inclusion Criteria:\n\n* Voluntarily participates in the study and provides written informed consent.\n* Male or female, age ≥ 18 and ≤ 80 years old\n* Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.\n* Has CNLC stage II to IIIa disease.\n* Has at least one measurable lesion according to mRECIST.\n* Child-Pugh class A or B.\n* ECOG performance status of 0 - 2.\n* Adequate hematologic and organ function.\n\nMain Exclusion Criteria:\n\n* Has a known allergy to the investigational product or related components, including human serum albumin and IL-2.\n* Has another incurable malignancy within 5 years before screening or concurrently.\n* Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.\n* Has received therapy aim to target lesion(s) within 12 weeks before screening.\n* Has hepatic encephalopathy within 4 weeks before screening.\n* Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage.\n* Has other active disease.","ALL","18 Years","80 Years",{"count":174,"type":175},48,"ESTIMATED","INTERVENTIONAL",[178],"PHASE2","This is a multicenter, randomized, open-label, controlled Phase 2 study in patients with unresectable hepatocellular carcinoma (uHCC).\n\nThe purpose of this study is to compare the efficacy and safety of GKL-006 Injection in combination with transarterial chemoembolization (TACE) versus TACE alone.",[181,182],"Hepatocellular Carcinoma (HCC)","Unresectable Hepatocellular Cancer",[184,185,27,186,187],"Hepatocellular 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