Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT05278195
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2022-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
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': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', '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': 'Specificity', 'timeFrame': 'baseline', 'description': 'The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.'}, {'measure': 'Sensitivity', 'timeFrame': 'baseline', 'description': 'The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.'}, {'measure': 'The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode', 'timeFrame': 'baseline', 'description': 'The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.'}, {'measure': 'Accuracy', 'timeFrame': 'baseline', 'description': 'Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'immune checkpoint iInhibitors', 'transarterial chemoembolization', 'real-world study'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32430997', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Villanueva A, Marrero JA, Schwartz M, Meyer T, Galle PR, Lencioni R, Greten TF, Kudo M, Mandrekar SJ, Zhu AX, Finn RS, Roberts LR; AASLD Panel of Experts on Trial Design in HCC. Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference. Hepatology. 2021 Jan;73 Suppl 1:158-191. doi: 10.1002/hep.31327. Epub 2020 Sep 9. No abstract available.'}, {'pmid': '33479224', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.'}, {'pmid': '32888471', 'type': 'BACKGROUND', 'citation': 'Ochoa de Olza M, Navarro Rodrigo B, Zimmermann S, Coukos G. Turning up the heat on non-immunoreactive tumours: opportunities for clinical development. Lancet Oncol. 2020 Sep;21(9):e419-e430. doi: 10.1016/S1470-2045(20)30234-5.'}, {'pmid': '34593621', 'type': 'BACKGROUND', 'citation': 'Pinato DJ, Murray SM, Forner A, Kaneko T, Fessas P, Toniutto P, Minguez B, Cacciato V, Avellini C, Diaz A, Boyton RJ, Altmann DM, Goldin RD, Akarca AU, Marafioti T, Mauri FA, Casagrande E, Grillo F, Giannini E, Bhoori S, Mazzaferro V. Trans-arterial chemoembolization as a loco-regional inducer of immunogenic cell death in hepatocellular carcinoma: implications for immunotherapy. J Immunother Cancer. 2021 Sep;9(9):e003311. doi: 10.1136/jitc-2021-003311.'}, {'pmid': '39604073', 'type': 'DERIVED', 'citation': 'Jin ZC, Zhou JW, Chen JJ, Ding R, Scheiner B, Wang SN, Li HL, Shen QX, Lu QY, Liu Y, Zhang WH, Luo B, Shi HB, Huang M, Wu YM, Yuan CW, Huang MS, Li JP, Wu JB, Zhu XL, Zhong BY, Zhou HF, Wang YQ, Gu SZ, Peng ZY, Zheng CS, Liu RB, Xu GH, Yang WZ, Xu AB, Liu DF, Qi X, Yeo YH, Zhu HD, Zhao Y, Pinato DJ, Ji F, Teng GJ. Longitudinal Body Composition Identifies Hepatocellular Carcinoma With Cachexia Following Combined Immunotherapy and Target Therapy (CHANCE2213). J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2705-2716. doi: 10.1002/jcsm.13615. Epub 2024 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to id\n\ntransarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intermediate 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. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);\n3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;\n4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;\n5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；\n\n7\\. Has repeated measurable intrahepatic lesions according to RECIST v1.1;\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. Missing follow-up data;'}, 'identificationModule': {'nctId': 'NCT05278195', 'acronym': 'CHANCEsub', 'briefTitle': 'Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers', 'orgStudyIdInfo': {'id': 'CHANCE-Biomarker'}}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao-Jun Teng, MD', 'role': 'CONTACT', 'email': 'gjteng@seu.edu.cn', 'phone': '+86 25 83272121'}, {'name': 'Hai-Dong Zhu, MD', 'role': 'CONTACT', 'email': 'zhuhaidong9509@163.com', 'phone': '+86-02583272121'}, {'name': 'Gao-Jun Teng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongda Hospital, Southeast University', '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-Jun Teng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda hospital, Southeast university, Nanjing, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Gao-jun Teng', 'investigatorAffiliation': 'Zhongda Hospital'}}}}