Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT06607120
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival(OS)', '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) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', '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 RECIST 1.1) or death due to any cause, whichever occurs first.'}, {'measure': 'PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)', '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': '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': 'Duration of Response (DOR) per RESCIST 1.1', 'timeFrame': 'up to approximately 2 years', 'description': 'DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.'}, {'measure': 'DOR per mRECIST', 'timeFrame': 'up to approximately 2 years', 'description': 'DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.'}, {'measure': 'Disease Control Rate (DCR) per RESCIST 1.1', 'timeFrame': 'up to approximately 2 years', 'description': 'DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.'}, {'measure': 'DCR per mRECIST', 'timeFrame': 'up to approximately 2 years', 'description': 'DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.'}, {'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, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'transarterial chemoembolization', 'immune checkpoint inhibitors', 'molecular target therapies', 'advanced stage', 'prognosis model'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.', 'detailedDescription': 'In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection for clinical practice and trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies 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 extrahepatic spread and/or macrovascular invasion;\n3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);\n4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;\n5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);\n6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;\n7. Has repeated measurable intrahepatic lesions;\n\nExclusion Criteria:\n\n1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;\n2. Unable to meet criteria of combination timeframe described above;\n3. Child-Pugh C or PS\\>2 or Severe hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT06607120', 'briefTitle': 'Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies', 'orgStudyIdInfo': {'id': 'CHANCE2420'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}], 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}, {'name': 'Hai-Dong Zhu, M.D', 'role': 'CONTACT', 'email': 'zhuhaidong9509@163.com', 'phone': '+86-02583272121'}], 'overallOfficials': [{'name': 'Gao- Teng, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda hospital, Southeast university, Nanjing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Gao-jun Teng', 'investigatorAffiliation': 'Zhongda Hospital'}}}}