Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07392866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C559147', 'term': 'regorafenib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-01-31', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) (Phase II)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).'}, {'measure': 'Incidence of Adverse Events (AEs) (Phase II)', 'timeFrame': 'Up to approximately 4 years', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.'}, {'measure': 'Overall Survival (OS) (Phase III)', 'timeFrame': 'Up to approximately 4 years', 'description': 'OS was defined as the time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'ORR was assessed by investigators per RECIST 1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DCR was assessed by investigators per RECIST 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR was assessed by investigators per RECIST 1.1'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'Up to approximately 4 years', 'description': 'TTP was assessed by investigators per RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'immune checkpoint inhibitors'], 'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma', 'detailedDescription': 'This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects participate voluntarily and sign informed consent.\n* Age ≥ 18 and ≤ 75 years old, male or female.\n* Histological or clinical diagnosis of HCC.\n* Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment\n* Previous treatment with a drug containing an immune checkpoint inhibitor failed.\n* Child-Pugh ≤7 , no history of hepatic encephalopathy.\n\nExclusion Criteria:\n\n* Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.\n* History of malignancy other than HCC within 5 years prior to the start of study treatment.\n* History of liver transplantation, or planned to receive liver transplantation.\n* Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.'}, 'identificationModule': {'nctId': 'NCT07392866', 'briefTitle': 'A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SHS006-II/III-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 SH006 in combination with bevacizumab and chemotherapy', 'interventionNames': ['Drug: SH006', 'Drug: Bevacizumab', 'Drug: Oxaliplatin injection', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 SH006 in combination with bevacizumab', 'interventionNames': ['Drug: SH006', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 SH006 in combination with chemotherapy', 'interventionNames': ['Drug: SH006', 'Drug: Oxaliplatin injection', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4 Regorafenib', 'interventionNames': ['Drug: Regorafenib']}], 'interventions': [{'name': 'SH006', 'type': 'DRUG', 'description': '15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1 SH006 in combination with bevacizumab and chemotherapy', 'Arm 2 SH006 in combination with bevacizumab', 'Arm 3 SH006 in combination with chemotherapy']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': '15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1 SH006 in combination with bevacizumab and chemotherapy', 'Arm 2 SH006 in combination with bevacizumab']}, {'name': 'Oxaliplatin injection', 'type': 'DRUG', 'description': '85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Arm 1 SH006 in combination with bevacizumab and chemotherapy', 'Arm 3 SH006 in combination with chemotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle', 'armGroupLabels': ['Arm 1 SH006 in combination with bevacizumab and chemotherapy', 'Arm 3 SH006 in combination with chemotherapy']}, {'name': 'Regorafenib', 'type': 'DRUG', 'description': '160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle', 'armGroupLabels': ['Arm 4 Regorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '211199', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Shukui Qin', 'role': 'CONTACT', 'email': 'qinsk81@163.com', 'phone': '86-13905158713'}, {'name': 'Shukui Qin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Tianyinshan Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jian Zhou', 'role': 'CONTACT', 'email': 'zhou.jian@zs-hospital.sh.cn', 'phone': '86-13801914007'}, {'name': 'Jian Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jie Min', 'role': 'CONTACT', 'email': 'minjie@sanhome.com', 'phone': '86-15121121360'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}