Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-18 @ 4:33 AM
Study NCT ID:
NCT04560894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to 3years'}, {'measure': 'Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1', 'timeFrame': 'up to 3years'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to 3years', 'description': 'PFS evaluated by investigator based on RECIST V1.1'}, {'measure': 'PFS', 'timeFrame': 'up to 3years', 'description': 'PFS evaluated by BICR based on mRECIST.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'up to 3years', 'description': 'ORR evaluated by BICR based on RECIST V1.1.'}, {'measure': 'ORR', 'timeFrame': 'up to 3years', 'description': 'ORR evaluated by BICR based on mRECIST.'}, {'measure': 'ORR', 'timeFrame': 'up to 3years', 'description': 'ORR evaluated by investigator based on RECIST V1.1'}, {'measure': 'Serum concentration of SCT-I10A and SCT510', 'timeFrame': 'up to 3years'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'up to 3years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40769977', 'type': 'DERIVED', 'citation': 'Zhao C, Zhang Y, Wang G, Zheng J, Chen W, Lu Z, Zhuang L, Gu S, Han L, Zheng Z, Yu Z, Yang Y, Sun H, Wei X, Cheng Y, Lin H, Zhu B, Wu G, Lei K, Wang W, Wang Y, Chen K, Xu X, Zheng C, Bi Y, Ding S, Zhang J, Li W, Liu H, Wang J, Liu X, Du Y, Cai L, Wang J, Luo Z, Xing B, Shen J, Yang L, Wu J, Jiang O, Peng Z, Liu X, Cao B, Shen L, Xu A, Li A, Chen S, Fu T, Chen J, Jin C, Zhang L, Lv J, Zhang C, Zhang X, Wang Y, Su H, Zhou Q, Gai W, Xie L, Xu J. Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. Signal Transduct Target Ther. 2025 Aug 6;10(1):249. doi: 10.1038/s41392-025-02333-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.\n* No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).\n* Child-Pugh ≤7 , no history of hepatic encephalopathy.\n* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.\n* At least one measurable lesion based on Recist1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate hematologic and organ function.\n\nExclusion Criteria:\n\n* Local treatment or surgery for liver lesions within 4 weeks.\n* Prior liver or other organ transplantation.\n* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.\n* Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.\n* Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.\n* Active known, or suspected autoimmune disease.\n* Any condition that is not suitable for participate in this study as determined by investigator.'}, 'identificationModule': {'nctId': 'NCT04560894', 'acronym': 'HCC', 'briefTitle': 'SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinocelltech Ltd.'}, 'officialTitle': 'SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial', 'orgStudyIdInfo': {'id': 'SCT-I10A-C301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCT-I10A+SCT510', 'interventionNames': ['Drug: SCT-I10A', 'Drug: SCT510']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sorafenib', 'interventionNames': ['Drug: Sorafenib 200mg']}], 'interventions': [{'name': 'SCT-I10A', 'type': 'DRUG', 'description': 'Participants receive SCT-I10A intravenously，200mg，d1，Q3w', 'armGroupLabels': ['SCT-I10A+SCT510']}, {'name': 'SCT510', 'type': 'DRUG', 'description': 'Participants receive SCT510 intravenously，15mg/kg，d1，Q3w', 'armGroupLabels': ['SCT-I10A+SCT510']}, {'name': 'Sorafenib 200mg', 'type': 'DRUG', 'description': 'Participants receive sorafenib orally，400mg bid', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '307 Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinocelltech Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}