Gastrointestinal Neoplasms Clinical Trial
Official title:
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | June 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma - Failed routine chemotherapy - Neoplasms can be evaluated by imaging - ECOGĀ«2 Exclusion Criteria: - Have systematic chemotherapy in 2 weeks - Be allergic to ultrasonic microbubbles and chemotherapeutics - Uncontrolled high blood pressure, cardiovascular disease - Active bleeding - Have serious mental and psychological disease |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Cancer Hospital |
China,
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. — View 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. Review. — View 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 T — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Serious and Non-Serious Adverse Events | 1 month | Yes | |
Secondary | Time to Disease Progression | one year | No |
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