Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-09 @ 11:35 PM
Study NCT ID:
NCT02233205
Status:
UNKNOWN
Last Update Posted:
2015-07-24
First Post:
2014-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010984', 'term': 'Platinum'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2014-08-31', 'studyFirstSubmitQcDate': '2014-09-04', 'lastUpdatePostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Serious and Non-Serious Adverse Events', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['microbubble', 'chemotherapy', 'alimentary'], 'conditions': ['Gastrointestinal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '23822453', 'type': 'RESULT', 'citation': 'Kotopoulis S, Dimcevski G, Gilja OH, Hoem D, Postema M. Treatment of human pancreatic cancer using combined ultrasound, microbubbles, and gemcitabine: a clinical case study. Med Phys. 2013 Jul;40(7):072902. doi: 10.1118/1.4808149.'}, {'pmid': '25151979', 'type': 'RESULT', 'citation': 'Dewitte H, Van Lint S, Heirman C, Thielemans K, De Smedt SC, Breckpot K, Lentacker I. The potential of antigen and TriMix sonoporation using mRNA-loaded microbubbles for ultrasound-triggered cancer immunotherapy. J Control Release. 2014 Nov 28;194:28-36. doi: 10.1016/j.jconrel.2014.08.011. Epub 2014 Aug 22.'}, {'pmid': '24856171', 'type': 'RESULT', 'citation': 'Fan Z, Kumon RE, Deng CX. Mechanisms of microbubble-facilitated sonoporation for drug and gene delivery. Ther Deliv. 2014 Apr;5(4):467-86. doi: 10.4155/tde.14.10. No abstract available.'}, {'pmid': '24164605', 'type': 'RESULT', 'citation': 'Feichtinger GA, Hofmann AT, Slezak P, Schuetzenberger S, Kaipel M, Schwartz E, Neef A, Nomikou N, Nau T, van Griensven M, McHale AP, Redl H. Sonoporation increases therapeutic efficacy of inducible and constitutive BMP2/7 in vivo gene delivery. Hum Gene Ther Methods. 2014 Feb;25(1):57-71. doi: 10.1089/hgtb.2013.113. Epub 2013 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.', 'detailedDescription': 'Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.\n\n1. Main purpose\n\n 1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.\n 2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.\n2. Secondary purpose\n\n 1. To observe tumor clinical benefit rate (CR+PR+SD).\n 2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma\n* Failed routine chemotherapy\n* Neoplasms can be evaluated by imaging\n* ECOG《2\n\nExclusion Criteria:\n\n* Have systematic chemotherapy in 2 weeks\n* Be allergic to ultrasonic microbubbles and chemotherapeutics\n* Uncontrolled high blood pressure, cardiovascular disease\n* Active bleeding\n* Have serious mental and psychological disease'}, 'identificationModule': {'nctId': 'NCT02233205', 'briefTitle': 'Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma', 'orgStudyIdInfo': {'id': '2014YJZ11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microbubbles & platinum and gemcitabine', 'description': 'In 30min after chemotherapy, inject ultrasonic microbubbles 1 ml once and inject 5 times in 20min and locate the ultrasonic probe on the lesion The chemotherapy of pancreatic is gemcitabine.The chemotherapy of liver metastases is oxaliplatin with taxol.', 'interventionNames': ['Device: ultrasonic microbubbles', 'Drug: platinum and gemcitabine']}], 'interventions': [{'name': 'ultrasonic microbubbles', 'type': 'DEVICE', 'otherNames': ['Sonovue'], 'description': 'inject 1ml once and five times in 20min, locate the probe on the lesion at the same time', 'armGroupLabels': ['microbubbles & platinum and gemcitabine']}, {'name': 'platinum and gemcitabine', 'type': 'DRUG', 'description': 'Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.', 'armGroupLabels': ['microbubbles & platinum and gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Yang, Doctor', 'role': 'CONTACT', 'email': '13681408183@163.com', 'phone': '0086-10-88196195'}, {'name': 'Yanjie Wang, Doctor', 'role': 'CONTACT', 'email': 'philinsss@163.com', 'phone': '0086-10-88196941'}, {'name': 'Yan Li, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wei Yang, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jifang Gong, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Wei, Doctor', 'role': 'CONTACT', 'email': '13681408183@163.com', 'phone': '0086-10-88196195'}, {'name': 'Yanjie Wang, Doctor', 'role': 'CONTACT', 'email': 'philinsss@163.com', 'phone': '0086-10-88196941'}], 'overallOfficials': [{'name': 'Kun Yan, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}, {'name': 'Lin Shen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief director', 'investigatorFullName': 'Kun Yan', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}