Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 3:14 AM
Study NCT ID:
NCT06632093
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-06', 'studyFirstSubmitDate': '2024-10-06', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to approximately 2 years', 'description': 'The OS is defined as the time from the initiation of any combination treatment to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival(PFS) (Overall)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.'}, {'measure': 'Progression free survival(PFS) of intra-hepatic lesions', 'timeFrame': 'Up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.'}, {'measure': 'Progression free survival(PFS) of extra-hepatic lesions', 'timeFrame': 'Up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.'}, {'measure': 'Progression free survival(PFS) of portal vein tumor thrombus (PVTT)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first.'}, {'measure': 'Objective response rate(ORR) per RESCIST 1.1', 'timeFrame': 'Up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.'}, {'measure': 'ORR per mRECIST', 'timeFrame': 'Up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.'}, {'measure': 'ORR of PVTT', 'timeFrame': 'Up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.'}, {'measure': 'Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0', 'timeFrame': 'Up to approximately 2 years', 'description': 'The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['BCLC Stage B Hepatocellular Carcinoma', 'BCLC Stage C Hepatocellular Carcinoma', 'Hepatic Arterial Infusion Chemotherapy', 'Lenvatinib', 'PD-1', 'Systemic Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;\n3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;\n4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;\n5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;\n6. Received at least 2 cycles of HAIC；\n7. Has repeated measurable intrahepatic lesions;\n8. Child-Pugh class A or B.\n\nExclusion Criteria:\n\n1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;\n2. With other malignant tumors;\n3. Unable to meet criteria of combination timeframe described above.'}, 'identificationModule': {'nctId': 'NCT06632093', 'briefTitle': 'HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC', 'orgStudyIdInfo': {'id': 'CHANCE2417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAIC plus Lenvatinib and PD-1 inhibitors', 'description': 'Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.', 'interventionNames': ['Procedure: hepatic artery infusion chemotherapy', 'Drug: Lenvatinib + PD-1 monoclonal antibody']}], 'interventions': [{'name': 'hepatic artery infusion chemotherapy', 'type': 'PROCEDURE', 'description': 'Hepatic arterial infusion chemotherapy including FOLFOX and RALOX', 'armGroupLabels': ['HAIC plus Lenvatinib and PD-1 inhibitors']}, {'name': 'Lenvatinib + PD-1 monoclonal antibody', 'type': 'DRUG', 'description': 'PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab', 'armGroupLabels': ['HAIC plus Lenvatinib and PD-1 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haibo Shao', 'role': 'CONTACT', 'email': 'dmuvictor@163.com', 'phone': '+8618940279150'}], 'facility': 'The first hospital of China medical university', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Jiaxi Liu', 'role': 'CONTACT', 'email': 'dmuvictor@163.com', 'phone': '+8618940279150'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Haibo Shao', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}