Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04961918
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)
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': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of randomization until the date of progression, assessed up to 36 months', 'description': 'progression-free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'From date of randomization until the date of death, assessed up to 36 months', 'description': 'objective response rate'}, {'measure': 'DCR', 'timeFrame': 'From date of randomization until the date of death, assessed up to 36 months', 'description': 'disease control rate'}, {'measure': 'OS', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 36 months', 'description': 'overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old and younger than 75 years; ECOG PS≤1; proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\\<2-times upper limit of normal; ALT\\<3-times upper limit of normal; AST\\<3-times upper limit of normal; serum creatine\\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent;\n\nExclusion Criteria:\n\n* cannot tolerate HAIC or lenvatinib or durvalumab; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy;'}, 'identificationModule': {'nctId': 'NCT04961918', 'briefTitle': 'The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial', 'orgStudyIdInfo': {'id': 'HILL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)', 'interventionNames': ['Procedure: Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)']}], 'interventions': [{'name': 'Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)', 'type': 'PROCEDURE', 'description': 'Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong-Ping Guo, M.D.', 'role': 'CONTACT', 'email': 'guorp@sysucc.org.cn', 'phone': '00862087342266'}, {'name': 'Wei Wei, Ph.D. M.D.', 'role': 'CONTACT', 'email': 'weiwei@sysucc.org.cn', 'phone': '00862087343790'}], 'facility': 'SUN YAT-SEN University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shaohua Li, M.D.', 'role': 'CONTACT', 'email': 'lishaoh@sysucc.org.cn', 'phone': '+8615088064187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rong-ping Guo', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}