<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/NCT03255343</url>
  </required_header>
  <id_info>
    <org_study_id>AFPREMED</org_study_id>
    <nct_id>NCT03255343</nct_id>
  </id_info>
  <brief_title>Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim</brief_title>
  <acronym>ImDendrim</acronym>
  <official_title>Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim &quot;[188Re]Rhenium Complex Coupled to an Imidazolic Ligand and Associated With a Dendrimer&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Association for the Advancement Medical Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>French Association for the Advancement Medical Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to&#xD;
      conventional therapy inoperable liver cancers by in situ introduction of ImDendrim.&#xD;
&#xD;
      Trial Design:&#xD;
&#xD;
      An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or&#xD;
      metastatic liver without standard therapeutic options for treatment including chemotherapy or&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to&#xD;
      conventional therapy inoperable liver cancers by in situ introduction of ImDendrim &quot;[188Re]&#xD;
      rhenium complex coupled to a imidazolic ligand and associated with a dendrimer&quot;.&#xD;
&#xD;
      Trial Design:&#xD;
&#xD;
        1. Type of the clinical Trial:&#xD;
&#xD;
           An, open-labeled and unicenter study in women or men with primary hepatocellular cancer&#xD;
           or metastatic liver without standard therapeutic options for treatment including&#xD;
           chemotherapy or surgery.&#xD;
&#xD;
        2. Duration and method The trial will be comprised of 12 weeks of continued observation&#xD;
           following in situ injection of ImDendrim into a subject suffering non-responding to&#xD;
           conventional therapy inoperable liver cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>10 patients with liver tumor non operable, with resistance to other classical chemotherapy, injected a single dose of IMDENDRIM 10 mCi per 1 cm²</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>size of tumor</measure>
    <time_frame>12 weeks</time_frame>
    <description>evaluation criteria for solid tumors RECIST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival PFS</measure>
    <time_frame>12 weeks</time_frame>
    <description>PFS-end-point was defined as either Imaging progression or death of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPFS</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hepatic free survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Efficacy and Safety</condition>
  <arm_group>
    <arm_group_label>IMDENDRIM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMDENDRIM</intervention_name>
    <description>In situ and intra tumoral injection of non removal nanodevice IMDENDRIM</description>
    <arm_group_label>IMDENDRIM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have given written informed consent.&#xD;
&#xD;
          2. Female or male aged 18 years and over.&#xD;
&#xD;
          3. Confirmed histological diagnosis of primary hepatocellular cancer or metastatic liver&#xD;
             without standard therapeutic options for treatment including chemotherapy or surgery.&#xD;
             Not more than 5 measurable lesions at least 20 mm in the longest diameter by spiral&#xD;
             Computed Tomography (CT) scan. Patients with hepatic tumor extended without&#xD;
             discontinuity to regional structures are accepted (including vascular axis, lymphatic&#xD;
             nodes and others organs namely pancreas, billiary vesicle and peritonea).&#xD;
&#xD;
          4. Life expectancy of 12 weeks or longer.&#xD;
&#xD;
          5. Patient with no contraindication to local anaesthesia.&#xD;
&#xD;
          6. Karnofsky index ≥ 70%&#xD;
&#xD;
          7. Negative pregnancy test for women of childbearing potential. -&#xD;
&#xD;
          8. Women should be under effective contraceptive method during at least trial period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major surgery within 4 weeks, or incompletely healed surgical incision before starting&#xD;
             study therapy.&#xD;
&#xD;
          2. Any metastasis no located in liver (liver tumor extended without discontinuity to&#xD;
             other regional structures are accepted, see inclusion criteria).&#xD;
&#xD;
          3. Pregnancy or breast feeding (women of child-bearing potential).&#xD;
&#xD;
          4. Comorbidity with a grave prognosis (estimated survival &lt;3 months) and/or worse then&#xD;
             the basic disease for which the patients will be included in the study.&#xD;
&#xD;
          5. Patients suffering from psychic disorders that make a comprehensive judgement&#xD;
             impossible, such as psychosis, hallucinations and/or depression.&#xD;
&#xD;
          6. Patients who are declared incompetent.&#xD;
&#xD;
          7. Female patients who are not using an acceptable method of contraception (oral&#xD;
             contraceptives, barrier methods, approved contraceptive implant, long-term injectable&#xD;
             contraception, intrauterine device or tubal ligation) OR are less than 1 year&#xD;
             postmenopausal or surgically sterile during their participation in this study (from&#xD;
             the time they sign the consent form) to prevent pregnancy.&#xD;
&#xD;
          8. Active hepatitis (B and/or C).&#xD;
&#xD;
          9. Allergy for I.V. contrast or anesthesic agents used.&#xD;
&#xD;
         10. Scan or MRI contra-indications: severe claustrophobia, metal shrapnel, implanted&#xD;
             pacemaker and/or neurostimulators.&#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>Bertrand NASSAR, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AFPREMED</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HAFID BELHADJ-TAHAR, MD, PhD</last_name>
    <phone>00336467722224</phone>
    <email>belhadj-tahar@afpremed.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nouredine SADEG, PhD</last_name>
    <phone>0033679343657</phone>
    <phone_ext>0033679343657</phone_ext>
    <email>nouredinesadeg@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tongji University Eastern Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guanghua YANG, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255343
org study id: AFPREMED
nct id: NCT03255343
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to
      conventional therapy inoperable liver cancers by in situ introduction of ImDendrim.

      Trial Design:

      An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or
      metastatic liver without standard therapeutic options for treatment including chemotherapy or
      surgery.
Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to
      conventional therapy inoperable liver cancers by in situ introduction of ImDendrim "[188Re]
      rhenium complex coupled to a imidazolic ligand and associated with a dendrimer".

      Trial Design:

        1. Type of the clinical Trial:

           An, open-labeled and unicenter study in women or men with primary hepatocellular cancer
           or metastatic liver without standard therapeutic options for treatment including
           chemotherapy or surgery.

        2. Duration and method The trial will be comprised of 12 weeks of continued observation
           following in situ injection of ImDendrim into a subject suffering non-responding to
           conventional therapy inoperable liver cancers.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 10 patients with liver tumor non operable, with resistance to other classical chemotherapy, injected a single dose of IMDENDRIM 10 mCi per 1 cm²
primary purpose: Treatment
masking: None (Open Label)
measure: size of tumor
time frame: 12 weeks
description: evaluation criteria for solid tumors RECIST
measure: Progression free survival PFS
time frame: 12 weeks
description: PFS-end-point was defined as either Imaging progression or death of any cause
measure: HPFS
time frame: 12 weeks
description: Hepatic free survival
arm group label: IMDENDRIM
arm group type: Experimental
intervention type: Device
intervention name: IMDENDRIM
description: In situ and intra tumoral injection of non removal nanodevice IMDENDRIM
arm group label: IMDENDRIM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bertrand NASSAR, MD, PhD
role: Study Director
affiliation: AFPREMED
last name: HAFID BELHADJ-TAHAR, MD, PhD
phone: 00336467722224
email: belhadj-tahar@afpremed.org
last name: Nouredine SADEG, PhD
phone: 0033679343657
phone ext: 0033679343657
email: nouredinesadeg@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Liver Neoplasms
sharing ipd: Undecided