Safety Study Of Combining Ultrasound Microbubbles And Chemotherapy To Treat Malignant Neoplasms Of Digestive System

Study Overview

Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

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.

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)

Gastrointestinal Neoplasms

DEVICE: ultrasonic microbubbles
DRUG: platinum and gemcitabine

2014YJZ11

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-23
First Submitted that Met QC Criteria 2014-09-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-24
First Posted (ESTIMATED) 2014-09-08	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DEVICE: ultrasonic microbubbles inject 1ml once and five times in 20min, locate the probe on the lesion at the same time DRUG: platinum and gemcitabine Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

DEVICE: ultrasonic microbubbles

inject 1ml once and five times in 20min, locate the probe on the lesion at the same time

DRUG: platinum and gemcitabine

Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants with Serious and Non-Serious Adverse Events		1 month

Secondary Outcome Measures	Measure Description	Time Frame
Time to Disease Progression		one year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yang Wei, Doctor

Phone Number: 0086-10-88196195

Email: 13681408183@163.com

Study Contact Backup

Name: Yanjie Wang, Doctor

Phone Number: 0086-10-88196941

Email: philinsss@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
Failed routine chemotherapy
Neoplasms can be evaluated by imaging
ECOG《2

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kun Yan, Master, Peking University Cancer Hospital & Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Patients

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Clinical Trial Record