Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-05 @ 7:27 AM
Study NCT ID:
NCT04183712
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2019-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D003132', 'term': 'Commerce'}, {'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}, {'id': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sensitivity and specificity of ctDNA', 'timeFrame': 'up to 2 years', 'description': 'sensitivity and specificity of ctDNA compared to clinical index（CA199，CEA）for monitoring tumour progression'}], 'primaryOutcomes': [{'measure': '3-year DFS', 'timeFrame': 'up to 3 years', 'description': '3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.'}], 'secondaryOutcomes': [{'measure': '3-year OS', 'timeFrame': 'up to 3 years', 'description': '3-year Overall survival rates'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gallbladder Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36854604', 'type': 'DERIVED', 'citation': 'Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.', 'detailedDescription': 'Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study. These information will be used to recommend target therapy which may be more likely to result in a beneficial response. Patients will receive target antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese#\n* Stable vital signs, ECOG:0-1;\n* Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.\n* Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components\n* Life expectancy of more than 18 weeks;\n* T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging.\n* Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\\^9/L, neutrophils≥1.5×10\\^9/L, platelets≥75×10\\^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;\n* Volunteer for this study, have written informed consent and have good Patient compliance;\n* Female patients of childbearing potential and their mates agree to avoid pregnancy.\n\nExclusion Criteria:\n\n* Have received following treatment before this study: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.\n* History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;\n* Have serious concurrent illness including, but not limited to uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure \\>21.3 Kpa or diastolic blood pressure \\>13.3 Kpa);\n* Have ongoing or active serious infection;\n* Have uncontrolled diabetes mellitus;\n* Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;\n* Active autoimmune diseases require long-term use of steroids or received allotransplantation\n* Other serious illness considered not suitable for this study by investigators.'}, 'identificationModule': {'nctId': 'NCT04183712', 'briefTitle': 'Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.', 'orgStudyIdInfo': {'id': 'LTGBCLYB2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afatinib with GEMOX', 'description': 'Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)', 'interventionNames': ['Drug: gemcitabine and oxaliplatin.', 'Drug: Afatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GEMOX', 'description': 'Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion）', 'interventionNames': ['Drug: gemcitabine and oxaliplatin.']}], 'interventions': [{'name': 'gemcitabine and oxaliplatin.', 'type': 'DRUG', 'otherNames': ['Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)'], 'description': 'GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.', 'armGroupLabels': ['Afatinib with GEMOX', 'GEMOX']}, {'name': 'Afatinib', 'type': 'DRUG', 'otherNames': ['Gilotrif(Boehringer-Ingelheim)'], 'description': 'Target therapy Drug: afatinib', 'armGroupLabels': ['Afatinib with GEMOX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingbin Liu, PHD', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '13918803900'}], 'facility': 'Renji hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingbin Liu, PHD', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '13918803900'}], 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yingbin Liu, PHD', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '+8613918803900'}], 'overallOfficials': [{'name': 'Yingbin Liu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Shanghai East Hospital of Tongji University', 'class': 'OTHER'}, {'name': 'Changshu Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': "Qinghai People's Hospital", 'class': 'OTHER'}, {'name': "The Second People's Hospital of Baoshan, Yunnan Province", 'class': 'UNKNOWN'}, {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, {'name': "The First People's Hospital of Nantong", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Yingbin Liu, MD, PhD, FACS', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}