Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT03345303
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-20', 'releaseDate': '2022-12-22'}], 'estimatedResultsFirstSubmitDate': '2022-12-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'at least 2 months', 'description': 'Objective response rate include response from stable disease to complete response based on RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'changes of platelet count', 'timeFrame': '7 days', 'description': 'changes of platelet count after injection of Bortezomib'}, {'measure': 'occurrence of peripheral neuritis', 'timeFrame': '7 days', 'description': 'occurrence of any feeling of numbness of limbs'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bortezomib'], 'conditions': ['Intrahepatic Cholangiocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38689424', 'type': 'DERIVED', 'citation': 'Zeng TM, Jiang TY, Yang G, Cheng Z, Lou C, Wei W, Tao CJ, Hu S, Wang H, Cui XW, Tan YX, Dong LW, Wang HY, Yuan ZG. Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial. Clin Transl Med. 2024 May;14(5):e1675. doi: 10.1002/ctm2.1675.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.', 'detailedDescription': "There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients.\n\nPrevious study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.\n\nSo the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;\n2. Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;\n3. The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;\n5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;\n6. Normal liver,kidney and bone marrow function；\n7. Subjects who understand and voluntarily signed a written informed consent form.\n\nExclusion Criteria:\n\n1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis\n2. There is any contraindication to use Bortezomib\n3. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).\n4. A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.\n5. Pregnant or lactating women.\n6. History of radiation within 4 weeks prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT03345303', 'briefTitle': 'Bortezomib in Intrahepatic Cholangiocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency', 'orgStudyIdInfo': {'id': 'EHBH-201708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bortezomib treatment', 'description': "'Bortezomib Injectable Solution", 'interventionNames': ['Drug: Bortezomib']}, {'type': 'NO_INTERVENTION', 'label': 'supportive care', 'description': 'supportive care'}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['velcade'], 'description': 'Bortezomib Injectable Solution', 'armGroupLabels': ['Bortezomib treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Wu, Ph.D', 'role': 'CONTACT', 'email': 'beizong999@sina.com', 'phone': '00862181875018'}], 'facility': 'Easter hepatobiliary surgery hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yexiong Tan, Ph.D', 'role': 'CONTACT', 'email': 'yxtan1214@163.COM', 'phone': '00862181875362'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhengang Yuan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Oncology Department', 'investigatorFullName': 'Zhengang Yuan', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-12-22', 'type': 'RELEASE'}, {'date': '2023-10-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shen Feng, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital'}}}}