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

Primary Purpose

Gastrointestinal Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ultrasonic microbubbles
platinum and gemcitabine
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring microbubble, chemotherapy, alimentary

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microbubbles & platinum and gemcitabine

Arm 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.

Outcomes

Primary Outcome Measures

Number of Participants with Serious and Non-Serious Adverse Events

Secondary Outcome Measures

Time to Disease Progression

Full Information

First Posted
August 31, 2014
Last Updated
July 23, 2015
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02233205
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. Main purpose To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma. To explore the largest mechanical index and ultrasonic treatment time which patients can endure. Secondary purpose To observe tumor clinical benefit rate (CR+PR+SD). To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
microbubble, chemotherapy, alimentary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microbubbles & platinum and gemcitabine
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
ultrasonic microbubbles
Other Intervention Name(s)
Sonovue
Intervention Description
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
Intervention Type
Drug
Intervention Name(s)
platinum and gemcitabine
Intervention Description
Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
Primary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Wei, Doctor
Phone
0086-10-88196195
Email
13681408183@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanjie Wang, Doctor
Phone
0086-10-88196941
Email
philinsss@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Yan, Master
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Shen, Doctor
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yang, Doctor
Phone
0086-10-88196195
Email
13681408183@163.com
First Name & Middle Initial & Last Name & Degree
Yanjie Wang, Doctor
Phone
0086-10-88196941
Email
philinsss@163.com
First Name & Middle Initial & Last Name & Degree
Yan Li, Doctor
First Name & Middle Initial & Last Name & Degree
Wei Yang, Doctor
First Name & Middle Initial & Last Name & Degree
Jifang Gong, Doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
23822453
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.
Results Reference
result
PubMed Identifier
25151979
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.
Results Reference
result
PubMed Identifier
24856171
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.
Results Reference
result
PubMed Identifier
24164605
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.
Results Reference
result

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

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