<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/NCT03236883</url>
  </required_header>
  <id_info>
    <org_study_id>NST-01</org_study_id>
    <nct_id>NCT03236883</nct_id>
  </id_info>
  <brief_title>Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer</brief_title>
  <acronym>HST</acronym>
  <official_title>Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell&#xD;
      transplantation in the treatment of pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allogeneic hematopoietic stem cell transplantation has been successfully used for the&#xD;
      treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem&#xD;
      cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus&#xD;
      tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST&#xD;
      in the treatment of unresectable pancreatic cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>3 months</time_frame>
    <description>Survival will be measured at 3 months after transplant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival（PFS）</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky Performance Status（KPS）</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pancreatic Cancer Stage III</condition>
  <condition>Pancreatic Cancer Stage IV</condition>
  <arm_group>
    <arm_group_label>GEM plus GPBSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GPBSC</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.</description>
    <arm_group_label>GEM plus GPBSC</arm_group_label>
    <arm_group_label>Gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GPBSC</intervention_name>
    <description>immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.</description>
    <arm_group_label>GEM plus GPBSC</arm_group_label>
    <arm_group_label>GPBSC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PET-CT/EUS-FNA cytologically confirmed stage III -Ⅳ of pancreatic cancer&#xD;
&#xD;
          -  Between 18 and 80 years old&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) ≥ 70%，Guaranteed treatment for 3 months&#xD;
&#xD;
          -  Normal functions of heart, lung and kidney&#xD;
&#xD;
          -  Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥&#xD;
             1,500/mm^3 、Platelet count ≥ 100,000/mm^3， start the treatment within 14 days after&#xD;
             these results meet the requirements&#xD;
&#xD;
          -  A life expectancy &gt; 3 months&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  HLA-haplotype-matched immediate family health donors who have been confirmed by&#xD;
             laboratory HLA genotypes&#xD;
&#xD;
          -  Interval the last anti-tumor treatment for more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Highly allergic or people with severe allergies&#xD;
&#xD;
          -  Brain metastasis or Primary central nervous system malignancy&#xD;
&#xD;
          -  Suffer from clinical illnesses that affect clinical trials, including but not limited&#xD;
             to： Uncontrollable diabetes；active infectious disease or uncontrollable infection;&#xD;
             acute and chronic liver disease; confirmation of HIV infection; uncontrollable&#xD;
             hypertension, symptomatic congestive heart-failure, unstable angina pectoris, and&#xD;
             myocardial infarction, uncontrollable arrhythmia over the last 6 months.&#xD;
&#xD;
          -  Combined heart, lung, kidney and other vital organs dysfunction&#xD;
&#xD;
          -  A serious coagulation dysfunction, a clear history of other tumors&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Mental illness, affecting the compliance of clinical trials&#xD;
&#xD;
          -  The patient will participate in other trials within 10 days prior to the trial or&#xD;
             While participating in other tests&#xD;
&#xD;
          -  Patients underwent weight loss by 10% and above within 6 weeks before the start of the&#xD;
             trial&#xD;
&#xD;
          -  Neutrophils&lt;500mm^3 or Platelet count&lt;50,000/mm^3&#xD;
&#xD;
          -  Need to drive and manipulate the machine during the trial&#xD;
&#xD;
        Donor's Inclusion Criteria:&#xD;
&#xD;
          -  First-degree relatives of patients&#xD;
&#xD;
          -  Age&lt;55 years old&#xD;
&#xD;
          -  Normal functions of heart, lung and kidney&#xD;
&#xD;
          -  Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥&#xD;
             1,500/mm^3 、Platelet count ≥ 100,000/mm^3、WBC≥ 3000/mm^3， start collecting stem cells&#xD;
             within 14 days after these results meet the requirements&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Donor's exclusion Criteria:&#xD;
&#xD;
          -  Highly allergic or people with severe allergies&#xD;
&#xD;
          -  The person who have history of atherosclerosis, venous thrombosis or autoimmune&#xD;
             disease&#xD;
&#xD;
          -  A serious coagulation dysfunction, a clear history of other tumors&#xD;
&#xD;
          -  Infectious disease or carriers&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Mental illness, affecting the compliance of clinical trials&#xD;
&#xD;
          -  WBC&lt;4000/mm^3、PLT&lt;70*10^9/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jihui Hao, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>He Ren, MD,PHD</last_name>
    <phone>022-23340123-3073</phone>
    <email>renhe@tjmuch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>30000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 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>Pancreatic 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/NCT03236883
org study id: NST-01
nct id: NCT03236883
lead sponsor: 
has dmc: Yes
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell
      transplantation in the treatment of pancreatic cancer.
Allogeneic hematopoietic stem cell transplantation has been successfully used for the
      treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem
      cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus
      tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST
      in the treatment of unresectable pancreatic cancer patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 3 months
description: Survival will be measured at 3 months after transplant.
measure: Progression free survival（PFS）
time frame: 3 months
measure: Overall survival (OS)
time frame: 3 months
measure: Response rate
time frame: 3 months
measure: Adverse Events
time frame: 3 months
measure: Karnofsky Performance Status（KPS）
time frame: 3 months
arm group label: GEM plus GPBSC
arm group type: Experimental
description: Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
arm group label: Gemcitabine
arm group type: Other
arm group label: GPBSC
arm group type: Other
intervention type: Drug
intervention name: Gemcitabine
description: Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
arm group label: GEM plus GPBSC
arm group label: Gemcitabine
intervention type: Other
intervention name: GPBSC
description: immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
arm group label: GEM plus GPBSC
arm group label: GPBSC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jihui Hao, MD, PHD
role: Principal Investigator
affiliation: Tianjin Medical University Cancer Institute and Hospital
last name: He Ren, MD,PHD
phone: 022-23340123-3073
email: renhe@tjmuch.com
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Gemcitabine