protocolSection identificationModule nctId: NCT06371157, orgStudyIdInfo id: AK104-308, briefTitle: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-02, primaryCompletionDateStruct date: 2025-10-25, completionDateStruct date: 2026-05-23, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma, conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 469, type: ESTIMATED, armsInterventionsModule interventions name: AK104, interventions name: Lenvatinib, interventions name: TACE, interventions name: Placebo for AK104, interventions name: Placebo for Lenvatinib, outcomesModule primaryOutcomes measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: PFS per RECIST 1.1, secondaryOutcomes measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST), secondaryOutcomes measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST, secondaryOutcomes measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST, secondaryOutcomes measure: Time to Response (TTR) per RECIST 1.1 and mRECIST, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, zip: 450004, country: China, contacts name: Hailiang Li, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410006, country: China, contacts name: Shanzhi Gu, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Zhongda Hospital Southeast University, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Gaojun Teng, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Shanxi Cancer Hospital, city: Taiyuan, state: Shanxi, zip: 030009, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Sichuan Cancer Hospital, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Yunnan Cancer Hospital, city: Kunming, state: Yunnan, zip: 650100, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Guoliang Shao, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False