Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 4:37 PM
Study NCT ID:
NCT04627012
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2020-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008107', 'term': 'Liver Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'C000707970', 'term': 'tislelizumab'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2020-11-08', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free-Survival(PFS)', 'timeFrame': '24 months', 'description': 'Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause'}, {'measure': 'Overall survival (OS)', 'timeFrame': '24 months', 'description': 'OS is the length of time from the date of randomization until death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '6 months', 'description': 'ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': '24 months', 'description': 'The proportion of patients who had a best response rating of complete response， partial response, or stable disease.'}, {'measure': 'Adverse events', 'timeFrame': '24 months', 'description': 'Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tislelizumab', 'Lenvatinib', 'Toripalimab', 'Sintilimab', 'Camrelizumab', 'Keytruda', 'Opdivo'], 'conditions': ['Hepatocellular Carcinoma', 'Anti-PD1 Antibody', 'Liver Diseases']}, 'descriptionModule': {'briefSummary': 'For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.', 'detailedDescription': 'Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. We aimed to describe the efficacy and safety of Lenvatinib combined anti-PD1 antibody in patients with hepatocellular carcinoma who can not receive redical therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;\n2. age between 18 and 75 years;\n3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.\n4. Previous use of any systemic therapy but intolerant, impotent or drug resistant.\n5. Child-Pugh class A or B;\n6. Eastern Cooperative Group performance status (ECOG) score of 0-2;\n7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \\>1,500/mm3\n8. Prothrombin time ≤18s or international normalized ratio \\< 1.7.\n9. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Cholangiocellular carcinoma (ICC);\n2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;\n3. The survival or patients less than 3 months.\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. Known history of HIV\n7. History of organ allograft\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.'}, 'identificationModule': {'nctId': 'NCT04627012', 'briefTitle': 'Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Effectiveness and Safety of Lenvatinib Combined Anti-programmed Death Immunotherapy for the Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'GYEYJR-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'description': '12 mg (or 8 mg) once daily (QD) oral dosing.'}, {'name': 'Opdivo', 'type': 'DRUG', 'description': '3mg/mg intravenously every 3 weeks'}, {'name': 'Camrelizumab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks'}, {'name': 'Keytruda', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks'}, {'name': 'Toripalimab', 'type': 'DRUG', 'description': '240mg intravenously every 3 weeks'}, {'name': 'Sintilimab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks'}, {'name': 'Tislelizumab', 'type': 'DRUG', 'description': '200mg intravenously every 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zhou Qunfang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}