<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/NCT03815461</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-KAL-PC-05</org_study_id>
    <nct_id>NCT03815461</nct_id>
  </id_info>
  <brief_title>Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer</brief_title>
  <official_title>Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of&#xD;
      nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable&#xD;
      or unresectable .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of&#xD;
      nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable&#xD;
      or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8,&#xD;
      S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day&#xD;
      cycle for 4-6 cycles.&#xD;
&#xD;
      During the study, if the subject's weight change was ≤10% from baseline, the dose was&#xD;
      calculated based on the measured value at baseline. If the change was &gt;10%, the body surface&#xD;
      area of the subject should be recalculated and the dose administered should be adjusted. .&#xD;
&#xD;
      Study treatment period Borderline resectable: According to the results of imaging&#xD;
      examination, MDT discussed to determine the surgical resectability and timing of surgery. The&#xD;
      chemotherapy time was 4-6 cycles.&#xD;
&#xD;
      Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging&#xD;
      examination, MDT determined the resectability of the operation. It was decided by the&#xD;
      investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or&#xD;
      radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">October 2, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>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>PFS</measure>
    <time_frame>up to 2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reaction rate</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Locally Advanced Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>experiment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nab-paclitaxel+S-1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel and S-1</intervention_name>
    <description>Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.</description>
    <arm_group_label>experiment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient compliance is good, the research process of this study can be understood, and&#xD;
             written informed consent is signed;&#xD;
&#xD;
          -  Age ≥ 18 years old, ≤ 75 years old;&#xD;
&#xD;
          -  Histologically or cytologically confirmed pancreatic adenocarcinoma；&#xD;
&#xD;
          -  no prior treatment;&#xD;
&#xD;
          -  Based on imaging findings, MDT decided patients intoborderline resectable (group A) or&#xD;
             unresectable (group B) (according to the resectability assessment criteria in the 2018&#xD;
             Pancreatic Cancer Comprehensive Care Guidelines);&#xD;
&#xD;
          -  ECOG&lt;2;&#xD;
&#xD;
          -  Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥&#xD;
             1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;&#xD;
&#xD;
          -  Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver&#xD;
             metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin &lt; 1.5 × ULN;&#xD;
&#xD;
          -  Renal function: serum creatinine is within normal range;&#xD;
&#xD;
          -  Patients without biliary obstruction, patients requiring biliary stent implantation&#xD;
             must be completed at least 7 days prior to enrollment;&#xD;
&#xD;
          -  Non-pregnant and lactating women, women of reproductive age/male should take effective&#xD;
             contraceptive measures during the study period and within 6 months after the end of&#xD;
             the study treatment;&#xD;
&#xD;
          -  No contraindication to the use of S-1and albumin-bound paclitaxel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had other malignant tumors within 5 years (except for cured cervical&#xD;
             cancer in situ or non-melanoma skin cancer);&#xD;
&#xD;
          -  Interstitial pneumonia or pulmonary fibrosis;&#xD;
&#xD;
          -  Severe pleural effusion or ascites;&#xD;
&#xD;
          -  Watery diarrhea;&#xD;
&#xD;
          -  There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active&#xD;
             period, people who have diabetes and poorly controlled by hypoglycemic drugs,&#xD;
             clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous&#xD;
             system disease or mental disorder;&#xD;
&#xD;
          -  Current or previous patients with grade II peripheral neuropathy;&#xD;
&#xD;
          -  Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;&#xD;
&#xD;
          -  Participated in other clinical researchers within 4 weeks prior to enrollment;&#xD;
&#xD;
          -  Patients who have undergone organ transplantation;&#xD;
&#xD;
          -  Patients considered by the investigator to be unfit for this trial.&#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>Zhou Aiping</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center/Cancer Hospital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhou Aiping</last_name>
    <phone>+86 13691161998</phone>
    <email>zhouap1825@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhou Aiping</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhou Aiping</last_name>
      <phone>+86 13691161998</phone>
      <email>zhouap1825@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Aiping Zhou</investigator_full_name>
    <investigator_title>Cancer Hospital &amp; Institute</investigator_title>
  </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>Paclitaxel</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/NCT03815461
org study id: CSPC-KAL-PC-05
nct id: NCT03815461
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of
      nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable
      or unresectable .
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of
      nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable
      or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8,
      S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day
      cycle for 4-6 cycles.

      During the study, if the subject's weight change was ≤10% from baseline, the dose was
      calculated based on the measured value at baseline. If the change was >10%, the body surface
      area of the subject should be recalculated and the dose administered should be adjusted. .

      Study treatment period Borderline resectable: According to the results of imaging
      examination, MDT discussed to determine the surgical resectability and timing of surgery. The
      chemotherapy time was 4-6 cycles.

      Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging
      examination, MDT determined the resectability of the operation. It was decided by the
      investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or
      radiotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: up to 2.5 years
measure: R0 resection rate
time frame: 6 months
measure: Overall survival rate
time frame: 2 years
measure: Overall survival
time frame: up to 2.5 years
measure: Adverse reaction rate
time frame: up to 2.5 years
arm group label: experiment group
arm group type: Experimental
description: Nab-paclitaxel+S-1
intervention type: Drug
intervention name: Nab-paclitaxel and S-1
description: Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
arm group label: experiment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhou Aiping
role: Principal Investigator
affiliation: National Cancer Center/Cancer Hospital, China
last name: Zhou Aiping
phone: +86 13691161998
email: zhouap1825@126.com
last name: Zhou Aiping
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Aiping Zhou
investigator title: Cancer Hospital & Institute
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel