Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2026-01-08 @ 8:11 PM
Study NCT ID:
NCT06333561
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative 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': 'C531958', 'term': 'lenvatinib'}, {'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'C000631724', 'term': 'camrelizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '6 months', 'description': 'ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'OS is the length of time from the date of inclusion until death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free-Survival', 'timeFrame': '12 months', 'description': 'Progression was defined as progressive disease by independent radiologic review'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic arterial infusion chemotherapy', 'Tislelizumab', 'Toripalimab', 'Sintilimab', 'Camrelizumab', 'Lenvatinib'], 'conditions': ['Hepatocellular Carcinoma', 'Lenvatinib', 'PD-1 Inhibitor', 'Hepatic Arterial Infusion Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.', 'detailedDescription': 'This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. primary infiltrative HCC according to MRI or CT imaging characteristics.\n2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n3. Lenvatinib as initial treatment.\n4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.\n5. no history of other malignancies.\n6. no tumor thrombus in the atrium or vena cava.\n\nExclusion Criteria:\n\n1. HCC with tumor capsule.\n2. under 18 years or over 75 years.\n3. TACE as initial treatment.\n4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.\n5. incomplete tumor imaging data.\n6. lost to follow-up after treatment within three months.'}, 'identificationModule': {'nctId': 'NCT06333561', 'briefTitle': 'HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study', 'orgStudyIdInfo': {'id': 'Liver Project 7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAIC+Len+PD-1 inhibitor group', 'description': 'HAIC combined with Lenatinib and PD-1 inhibitor group', 'interventionNames': ['Procedure: Hepatic arterial infusion chemotherapy', 'Drug: Lenvatinib', 'Drug: Tislelizumab', 'Drug: Toripalimab', 'Drug: Sintilimab', 'Drug: Camrelizumab']}, {'label': 'Len group', 'description': 'Lenvatinib alone', 'interventionNames': ['Drug: Lenvatinib']}], 'interventions': [{'name': 'Hepatic arterial infusion chemotherapy', 'type': 'PROCEDURE', 'description': 'Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'description': '12 mg (body weight ≥60 kg) , 8 mg (body weight \\<60 kg) orally once a day', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group', 'Len group']}, {'name': 'Tislelizumab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group']}, {'name': 'Toripalimab', 'type': 'DRUG', 'description': '240mg intravenously every 3 weeks', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group']}, {'name': 'Sintilimab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group']}, {'name': 'Camrelizumab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks', 'armGroupLabels': ['HAIC+Len+PD-1 inhibitor group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qunfang Zhou, Md', 'role': 'CONTACT', 'email': 'zhouqun988509@163.com', 'phone': '8619868000115'}, {'name': 'Feng Duan, MD', 'role': 'CONTACT', 'email': 'duanfeng@vip.sina.com', 'phone': '8613910984586'}], 'facility': 'Chinese PLA General hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qunfang Zhou, MD', 'role': 'CONTACT', 'email': 'zhouqun988509@163.com', 'phone': '86 19868000115'}, {'name': 'Feng Duan, MD', 'role': 'CONTACT', 'email': 'duanfeng@vip.sina.com', 'phone': '86 13910984586'}], 'overallOfficials': [{'name': 'Feng Duan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhou Qunfang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}