NCT02233205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

August 31, 2014

Last Update Submit

July 23, 2015

Conditions

Gastrointestinal Neoplasms

Keywords

microbubblechemotherapyalimentary

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    1 month

Secondary Outcomes (1)

  • Time to Disease Progression

    one year

Study Arms (1)

microbubbles & platinum and gemcitabine

EXPERIMENTAL

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 microbubblesDrug: platinum and gemcitabine

Interventions

ultrasonic microbubblesDEVICE

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

Also known as: Sonovue
microbubbles & platinum and gemcitabine
platinum and gemcitabineDRUG

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

microbubbles & platinum and gemcitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23822453RESULT

  • 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.

    PMID: 25151979RESULT

  • 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.

    PMID: 24856171RESULT

  • 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.

    PMID: 24164605RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

PlatinumGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Kun Yan, Master

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • Lin Shen, Doctor

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Wei, Doctor

CONTACT

0086-10-8819619513681408183@163.com

Yanjie Wang, Doctor

CONTACT

0086-10-88196941philinsss@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief director

Study Record Dates

First Submitted

August 31, 2014

First Posted

September 8, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

CN(1)