Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
NCT ID: NCT02233205
Last Updated: 2015-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2014-10-31
2016-06-30
Brief Summary
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Detailed Description
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1. Main purpose
1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
2. Secondary purpose
1. To observe tumor clinical benefit rate (CR+PR+SD).
2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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microbubbles & platinum and gemcitabine
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.
ultrasonic microbubbles
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
platinum and gemcitabine
Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
Interventions
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ultrasonic microbubbles
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
platinum and gemcitabine
Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed routine chemotherapy
* Neoplasms can be evaluated by imaging
* ECOG《2
Exclusion Criteria
* Be allergic to ultrasonic microbubbles and chemotherapeutics
* Uncontrolled high blood pressure, cardiovascular disease
* Active bleeding
* Have serious mental and psychological disease
18 Years
75 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Kun Yan
chief director
Principal Investigators
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Kun Yan, Master
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Lin Shen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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2014YJZ11
Identifier Type: -
Identifier Source: org_study_id
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