<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/NCT04433169</url>
  </required_header>
  <id_info>
    <org_study_id>2020HNRT02</org_study_id>
    <nct_id>NCT04433169</nct_id>
  </id_info>
  <brief_title>All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck</brief_title>
  <acronym>Aplus</acronym>
  <official_title>A Prospective, Open-label, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of All-trans Retinoic Acid (ATRA) in the Treatment of Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</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 is a prospective, open-label, randomized controlled clinical intervention study to&#xD;
      evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with&#xD;
      recurrent metastatic adenoid cystic carcinoma of the head and neck.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (CR+PR)</measure>
    <time_frame>6 months</time_frame>
    <description>Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Grade 3-4 Toxicity</measure>
    <time_frame>6 months</time_frame>
    <description>Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>6 months</time_frame>
    <description>Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Adenoid Cystic Carcinoma of the Head and Neck</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>All-trans Retinoic Acid</intervention_name>
    <description>ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Ailike</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VEGFR inhibitor</intervention_name>
    <description>VEGFR inhibitor</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>chemotherapy</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Age ≥ 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3.&#xD;
        Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with&#xD;
        measurable disease (≥10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients&#xD;
        with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria&#xD;
        below:&#xD;
&#xD;
          1. Criteria for routine blood test: (no blood transfusion within 14 days)&#xD;
&#xD;
               1. HB ≥ 90 g/L;&#xD;
&#xD;
               2. WBC ≥ 3.5 × 109/L and &lt; 10 × 109/L;&#xD;
&#xD;
               3. ANC ≥ 1.5 × 109/L;&#xD;
&#xD;
               4. PLT ≥ 80 × 109/L&#xD;
&#xD;
          2. Criteria for biochemical tests:&#xD;
&#xD;
               1. BIL &lt; 1.25 × upper limit of normal (ULN)&#xD;
&#xD;
               2. ALT and AST &lt; 2.5 × ULN; in the presence of metastases to liver, ALT and AST &lt; 5&#xD;
                  × ULN;&#xD;
&#xD;
               3. Serum Cr ≤ 1 × ULN, endogenous creatinine clearance &gt; 50 mL/min (Cockcroft-Gault&#xD;
                  equation); 5. Subjects who volunteer to participate in this study, sign the&#xD;
                  informed consent, have good compliance and cooperate in follow-up; 6. Patients&#xD;
                  who, in the doctor's opinion, can benefit from the treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma&#xD;
             or cervical carcinoma in situ;&#xD;
&#xD;
          2. Coagulation abnormal (INR&gt;1.5, APTT&gt;1.5×ULN), history of gastrointestinal hemorrhage&#xD;
             in the past 6 months or bleeding tendency [e.g., presence of active ulcer focus in the&#xD;
             stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3&#xD;
             months];&#xD;
&#xD;
          3. Confirmed hypersensitivity to ATRA;&#xD;
&#xD;
          4. Grade I and above coronary artery diseases, arrhythmias [including QTc prolongation&#xD;
             (males: &gt; 450 ms, females: &gt; 470 ms)] and cardiac dysfunction;&#xD;
&#xD;
          5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea,&#xD;
             vomiting, chronic diarrhea and intestinal obstruction, etc.);&#xD;
&#xD;
          6. Pregnant or lactating women;&#xD;
&#xD;
          7. History of psychotropic abuse with abstinence failure, or existing mental disorder;&#xD;
&#xD;
          8. Participation in other drug clinical trials within 4 weeks;&#xD;
&#xD;
          9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent&#xD;
             the patient from completing the study, as judged by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Guopei Zhu, M.D</last_name>
    <phone>021-23271699</phone>
    <phone_ext>5665</phone_ext>
    <email>antica@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lulu Ye, Master</last_name>
      <phone>021-23271699</phone>
      <phone_ext>5665</phone_ext>
      <email>yee166@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 31, 2021</last_update_submitted>
  <last_update_submitted_qc>January 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Adenoid Cystic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tretinoin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04433169
org study id: 2020HNRT02
nct id: NCT04433169
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, open-label, randomized controlled clinical intervention study to
      evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with
      recurrent metastatic adenoid cystic carcinoma of the head and neck.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (CR+PR)
time frame: 6 months
description: Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
measure: Number of Participants With at Least One Grade 3-4 Toxicity
time frame: 6 months
description: Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
measure: Progression-Free Survival
time frame: 6 months
description: Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.
arm group label: Experimental group
arm group type: Experimental
description: ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.
arm group label: Control group
arm group type: Active Comparator
description: The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
intervention type: Drug
intervention name: All-trans Retinoic Acid
description: ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
arm group label: Experimental group
other name: Ailike
intervention type: Drug
intervention name: VEGFR inhibitor
description: VEGFR inhibitor
arm group label: Control group
intervention type: Drug
intervention name: Chemotherapy
description: chemotherapy
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guopei Zhu, M.D
phone: 021-23271699
phone ext: 5665
email: antica@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Adenoid Cystic
mesh term: Tretinoin
sharing ipd: No