Clinical trial NCT02233205: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
Official title: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Neoplasms
Keywords: microbubble
chemotherapy
alimentary
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.

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)

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
* Failed routine chemotherapy
* Neoplasms can be evaluated by imaging
* ECOG《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

Primary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 1 month
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Kun Yan, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.