<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/NCT03830606</url>
  </required_header>
  <id_info>
    <org_study_id>CH-GI-091</org_study_id>
    <nct_id>NCT03830606</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma</brief_title>
  <official_title>Phase II Study of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aiping Zhou</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>
      Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options.&#xD;
      Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced&#xD;
      biliary tract adenocarcinoma for the first-line treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given&#xD;
      the morphologic and histologic similarities between pancreatic cancer and biliary tract&#xD;
      adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for&#xD;
      biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma&#xD;
      will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface&#xD;
      area&lt;1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface&#xD;
      area&gt;1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the&#xD;
      efficacy and safety of the combination treatment, and expect to provide a more effective&#xD;
      treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint&#xD;
      is objective response rate(ORR), and the secondary endpoints are progression-free&#xD;
      survival(PFS), overall survival(OS) and the safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2016</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 2, 2018</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>
    <intervention_model_description>Patients with untreated advanced biliary tract adenocarcinoma</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective response rate（ORR）</measure>
    <time_frame>6 month</time_frame>
    <description>Assessed by RESIST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>6 month</time_frame>
    <description>Assessed by Kaplan-Meier curve，From date of randomization until date of first documented PD, date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival time (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed by Kaplan-Meier curve，From date of randomization until date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety profile: assessed by CTCAE v4.0</measure>
    <time_frame>1 year</time_frame>
    <description>Patients with treatment-related adverse events assessed by CTCAE v4.0 to determine the tolerability of patients with Advanced Biliary Tract Adenocarcinoma</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Biliary Tract Cancer</condition>
  <arm_group>
    <arm_group_label>Nab-paclitaxel Plus S-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area&lt;1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area&gt;1.5 m2; D1-14, q3w)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel,S-1</intervention_name>
    <description>Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area &lt; 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area &gt;1.5 m2; D1-14, q3w)</description>
    <arm_group_label>Nab-paclitaxel Plus S-1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age, years: 18-70&#xD;
&#xD;
          -  Histologically and cytologically confirmed advanced biliary tract adenocarcinoma,&#xD;
             unresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life&#xD;
             expectancy ≥12 weeks;&#xD;
&#xD;
          -  Untreated; more than 6 months after the last adjuvant chemotherapy (does not include&#xD;
             taxanes and S1);&#xD;
&#xD;
          -  Laboratory examination within 14 days before entering the study should meet following&#xD;
             requirements:&#xD;
&#xD;
        ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no&#xD;
        liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x&#xD;
        ULN&#xD;
&#xD;
          -  Both male and female subjects of potential fertility have to agree effective birth&#xD;
             control during the entire study&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent other effective treatment (including radiotherapy)&#xD;
&#xD;
          -  Resectable patients&#xD;
&#xD;
          -  Allergy history to other drugs in the same class patients with pregnancy or lactation&#xD;
&#xD;
          -  Known severe internal medical diseases&#xD;
&#xD;
          -  Abnormal heart function or relevant history of myocardial infarction and severe&#xD;
             arrhythmia&#xD;
&#xD;
          -  Immunocompromised patients, such as HIV positive&#xD;
&#xD;
          -  Uncontrollable mental illness&#xD;
&#xD;
          -  Other conditions the researchers considered ineligible for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Chief physician</investigator_title>
  </responsible_party>
  <keyword>Nab-paclitaxel, S-1, Advanced Biliary Tract Adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Biliary Tract 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/NCT03830606
org study id: CH-GI-091
nct id: NCT03830606
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options.
      Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced
      biliary tract adenocarcinoma for the first-line treatment.
Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given
      the morphologic and histologic similarities between pancreatic cancer and biliary tract
      adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for
      biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma
      will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface
      area<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface
      area>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the
      efficacy and safety of the combination treatment, and expect to provide a more effective
      treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint
      is objective response rate(ORR), and the secondary endpoints are progression-free
      survival(PFS), overall survival(OS) and the safety.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with untreated advanced biliary tract adenocarcinoma
primary purpose: Treatment
masking: None (Open Label)
measure: objective response rate（ORR）
time frame: 6 month
description: Assessed by RESIST
measure: Progression free survival (PFS)
time frame: 6 month
description: Assessed by Kaplan-Meier curve，From date of randomization until date of first documented PD, date of death
measure: overall survival time (OS)
time frame: 1 year
description: Assessed by Kaplan-Meier curve，From date of randomization until date of death
measure: safety profile: assessed by CTCAE v4.0
time frame: 1 year
description: Patients with treatment-related adverse events assessed by CTCAE v4.0 to determine the tolerability of patients with Advanced Biliary Tract Adenocarcinoma
arm group label: Nab-paclitaxel Plus S-1
arm group type: Experimental
description: Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)
intervention type: Drug
intervention name: Nab-paclitaxel,S-1
description: Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
arm group label: Nab-paclitaxel Plus S-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Aiping Zhou
investigator title: Chief physician
mesh term: Adenocarcinoma
mesh term: Biliary Tract Neoplasms
mesh term: Paclitaxel