[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-hepatocellular-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-hepatocellular-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609073","phase-2-gkl-006-combined-with-tace-in-treatment-of-unresectable-hepatocellular-carcinoma-100609073",false,"NCT07209813","GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular 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":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Hepatocellular Carcinoma (HCC)","Unresectable Hepatocellular Cancer",[30,31,32,33,34],"Hepatocellular carcinoma","iNKT","GKL-006","Immunotherapy","Cell therapy","RECRUITING","2026-08-13",{"date":38,"type":39},"2026-08-17","ACTUAL",{"date":41,"type":39},"2025-11-14",{"date":43,"type":21},"2027-10-31",{"name":45,"class":46},"Beijing Gene Key Life Technology Co., Ltd","INDUSTRY",7]