<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233205</url>
  </required_header>
  <id_info>
    <org_study_id>2014YJZ11</org_study_id>
    <nct_id>NCT02233205</nct_id>
  </id_info>
  <brief_title>Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System</brief_title>
  <official_title>Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the&#xD;
      therapeutic effects. The main purpose is to identify the safety of combining ultrasonic&#xD;
      microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from&#xD;
      alimentary system and pancreatic carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the&#xD;
      therapeutic effects.&#xD;
&#xD;
        1. Main purpose&#xD;
&#xD;
             1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics&#xD;
                to treat malignant neoplasms of hepatic metastases from alimentary system and&#xD;
                pancreatic carcinoma.&#xD;
&#xD;
             2. To explore the largest mechanical index and ultrasonic treatment time which&#xD;
                patients can endure.&#xD;
&#xD;
        2. Secondary purpose&#xD;
&#xD;
             1. To observe tumor clinical benefit rate (CR+PR+SD).&#xD;
&#xD;
             2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Gastrointestinal Neoplasms</condition>
  <arm_group>
    <arm_group_label>microbubbles &amp; platinum and gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasonic microbubbles</intervention_name>
    <description>inject 1ml once and five times in 20min, locate the probe on the lesion at the same time</description>
    <arm_group_label>microbubbles &amp; platinum and gemcitabine</arm_group_label>
    <other_name>Sonovue</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>platinum and gemcitabine</intervention_name>
    <description>Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.</description>
    <arm_group_label>microbubbles &amp; platinum and gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological diagnosis of liver metastases from alimentary system and pancreatic&#xD;
             carcinoma&#xD;
&#xD;
          -  Failed routine chemotherapy&#xD;
&#xD;
          -  Neoplasms can be evaluated by imaging&#xD;
&#xD;
          -  ECOG《2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have systematic chemotherapy in 2 weeks&#xD;
&#xD;
          -  Be allergic to ultrasonic microbubbles and chemotherapeutics&#xD;
&#xD;
          -  Uncontrolled high blood pressure, cardiovascular disease&#xD;
&#xD;
          -  Active bleeding&#xD;
&#xD;
          -  Have serious mental and psychological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kun Yan, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lin Shen, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Wei, Doctor</last_name>
    <phone>0086-10-88196195</phone>
    <email>13681408183@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yanjie Wang, Doctor</last_name>
    <phone>0086-10-88196941</phone>
    <email>philinsss@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Yang, Doctor</last_name>
      <phone>0086-10-88196195</phone>
      <email>13681408183@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yanjie Wang, Doctor</last_name>
      <phone>0086-10-88196941</phone>
      <email>philinsss@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yan Li, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wei Yang, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jifang Gong, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>23822453</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>25151979</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>24856171</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24164605</PMID>
  </results_reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>July 23, 2015</last_update_submitted>
  <last_update_submitted_qc>July 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Kun Yan</investigator_full_name>
    <investigator_title>chief director</investigator_title>
  </responsible_party>
  <keyword>microbubble</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>alimentary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233205
org study id: 2014YJZ11
nct id: NCT02233205
lead sponsor: 
has dmc: Yes
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)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: 1 month
measure: Time to Disease Progression
time frame: one year
arm group label: microbubbles & platinum and gemcitabine
arm group type: Experimental
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: ultrasonic microbubbles
description: inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
arm group label: microbubbles & platinum and gemcitabine
other name: Sonovue
intervention type: Drug
intervention name: platinum and gemcitabine
description: Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
arm group label: microbubbles & platinum and gemcitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kun Yan, Master
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Lin Shen, Doctor
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Yang Wei, Doctor
phone: 0086-10-88196195
email: 13681408183@163.com
last name: Yanjie Wang, Doctor
phone: 0086-10-88196941
email: philinsss@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
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.
PMID: 23822453
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.
PMID: 25151979
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.
PMID: 24856171
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.
PMID: 24164605
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Kun Yan
investigator title: chief director
mesh term: Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gemcitabine