Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-02 @ 3:46 AM
Study NCT ID:
NCT06327269
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Diagnosis and Therapy in LDLT Patients With High-risk 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival with adjuvant therapy', 'timeFrame': '2 years', 'description': 'Lenvatinib treatment may prolong the recurrence-free survival rate after LDLT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['living donor liver transplantation (LDLT)', 'hepatocellular carcinoma (HCC)', 'PET', 'proton', 'yttrium 90', 'Lenvatinib', 'adjuvant treatment'], 'conditions': ['High Risk of Recurrence']}, 'referencesModule': {'references': [{'pmid': '33365268', 'type': 'RESULT', 'citation': 'Han B, Ding H, Zhao S, Zhang Y, Wang J, Zhang Y, Gu J. Potential Role of Adjuvant Lenvatinib in Improving Disease-Free Survival for Patients With High-Risk Hepatitis B Virus-Related Hepatocellular Carcinoma Following Liver Transplantation: A Retrospective, Case Control Study. Front Oncol. 2020 Dec 7;10:562103. doi: 10.3389/fonc.2020.562103. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Targeted therapy is acceptable within 1-2 months after liver transplantation.\n* Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.\n* All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.\n* The definition of high-risk patients:\n* The PET scan is positive before LDLT;\n* Tumors beyond USCF criteria\n* Poorly-differentiated tumor;\n* The patients who has poor AFP response (\\<15%)or AFP\\>400 ng/ml after LRT after conventional LRT (RFA、PEI or TACE)\n\nExclusion Criteria\n\n* Life expectancy is less than 3 months\n* Patients are with other malignant tumors simultaneously.\n* Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.\n* Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).\n* Preoperative history of severe cardiovascular disease: congestive heart failure \\> NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.\n* History of HIV infection.\n* Severe clinical active infections (\\> NCI-CTCAE version 3.0).\n* Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).\n* Patients with kidney diseases requires renal dialysis.\n* Drug abuse, medical symptoms, mental illness or social status that may interfere with participants' participation in research or evaluation of research results.\n* Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding."}, 'identificationModule': {'nctId': 'NCT06327269', 'briefTitle': 'Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'MOHW111-TDU-B-221-114009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A new generation of targeted therapies and adjuvant therapy after LDLT.', 'description': 'The proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. Lenvatinib is applied to adjuvant therapy after LDLT.', 'interventionNames': ['Drug: Lenvatinib 10 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prolong the recurrence-free survival to high risk of HCC after LDLT', 'description': 'Lenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival', 'interventionNames': ['Drug: Lenvatinib 10 mg']}], 'interventions': [{'name': 'Lenvatinib 10 mg', 'type': 'DRUG', 'otherNames': ['Lenvima®'], 'description': 'Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.', 'armGroupLabels': ['A new generation of targeted therapies and adjuvant therapy after LDLT.', 'prolong the recurrence-free survival to high risk of HCC after LDLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Che Lin, Ph.D', 'role': 'CONTACT', 'email': 'chihchelin@cgmh.org.tw', 'phone': '+88677317123', 'phoneExt': '8880'}, {'name': 'I-Hsuan Chen, Ph.D', 'role': 'CONTACT', 'email': 'ann0401@cgmh.org.tw', 'phone': '+88677317123', 'phoneExt': '8582'}], 'facility': 'Department of Surgery', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Chih-Che Lin, Ph.D', 'role': 'CONTACT', 'email': 'chihchelin@cgmh.org.tw', 'phone': '+88677317123', 'phoneExt': '8880'}, {'name': 'I-Hsuan Chen, Ph.D', 'role': 'CONTACT', 'email': 'ann0401@cgmh.org.tw', 'phone': '+88677317123', 'phoneExt': '8582'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Welfare, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}