<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/NCT03276156</url>
  </required_header>
  <id_info>
    <org_study_id>Ahead-G001</org_study_id>
    <nct_id>NCT03276156</nct_id>
  </id_info>
  <brief_title>Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric Cancer</brief_title>
  <official_title>Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang Cancer Hospital</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>
      The purpose of this study is to determine the maximum tolerated dose (MTD)and safety of&#xD;
      Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or&#xD;
      gastroesophageal junction adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 23, 2016</start_date>
  <completion_date type="Anticipated">February 22, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 22, 2018</primary_completion_date>
  <phase>Phase 1</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>Progression Free Survival(PFS)</measure>
    <time_frame>Event driven, an expected average of 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>An expected average of 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>An expected average of 12months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate(DCR)</measure>
    <time_frame>An expected average of 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate(ORR)</measure>
    <time_frame>An expected average of 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life(QoL)</measure>
    <time_frame>An expected average of 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib plus S-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib (425/500/675/750mg,qd,p.o.) concomitantly with S-1 (80mg to 120 mg, qd,days1-14, q3w, p.o.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib plus S-1</intervention_name>
    <description>Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);</description>
    <arm_group_label>Apatinib plus S-1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fully informed consent prior to any specific research procedure.&#xD;
&#xD;
          2. Adult patients, aged ≥18 years;&#xD;
&#xD;
          3. Imaging test confirmed the progression after first-line treatment of advanced gastric&#xD;
             adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.&#xD;
&#xD;
               -  S-1 was not used in the first-line treatment&#xD;
&#xD;
               -  If patient relapse in 6 months after adjuvant chemotherapy or neoadjuvant&#xD;
                  chemotherapy, the adjuvant chemotherapy or neoadjuvant chemotherapy was regarded&#xD;
                  as the first-line treatment.&#xD;
&#xD;
          4. Adjuvant chemotherapy or neoadjuvant chemotherapy was allowed if the first-line&#xD;
             treatment started beyond 6 months after the end of previous treatment.&#xD;
&#xD;
          5. During the research ,patient should be willing and be able to follow the process&#xD;
             treatment ,follow up and tests.&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.&#xD;
&#xD;
          7. Survival expectation ≥ 16 weeks from the planned first dosing .&#xD;
&#xD;
          8. During the 28 days prior to the first dosing, hematological, biochemical and Organ&#xD;
             Functions:HB ≥ 9.0 g/dL, ANC ≥ 1.5×109/L,WBC&gt;3×109/L， PLT ≥ 100×109/L, BIL &lt; 1.5×ULN,&#xD;
             ALT or AST &lt; 2.5×ULN (or &lt; 5×ULN in patients with liver metastases), Serum Cr ≤&#xD;
             1.5×ULN;&#xD;
&#xD;
          9. Lesions ,measurable and/or unmeasurable,at least one,can be assessed by imaging during&#xD;
             the baseline and follow-up measurement.&#xD;
&#xD;
               -  Localized mass in gastric or Gastroesophageal Junction belongs to unmeasurable&#xD;
                  Lesions.&#xD;
&#xD;
         10. Women, those postmenopausal or of child-bearing age, but the pregnancy test results&#xD;
             (serum or urine) within 28 days before treatment is negative, and the results should&#xD;
             be confirmed in day 1 of the treatment.&#xD;
&#xD;
               -  Postmenopausal women are defined as :woman's menstrual periods have ceased for 1&#xD;
                  year or longer after exogenous hormone therapy;&#xD;
&#xD;
               -  Women, aged&gt;50years,serum LH and FSH level show a postmenopause;&#xD;
&#xD;
               -  Woman has radiation induced ovarian failure,and gone without a period for over 12&#xD;
                  consecutive months;&#xD;
&#xD;
               -  Woman has chemotherapy-induced menopause and gone without a period for over 12&#xD;
                  consecutive months;&#xD;
&#xD;
               -  sterilization operation( hysterectomy or bilateral oophorectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has participated in another clinical trial in progress.&#xD;
&#xD;
          2. Has received more than one chemotherapy regimens after disease progression(except for&#xD;
             those who has receiced adjuvant chemotherapy or neoadjuvant chemotherapy 6 months or&#xD;
             longer)&#xD;
&#xD;
          3. Previous therapy with S-1&#xD;
&#xD;
          4. Has received VEGFR inhibitor, such as Sorafenib,Sunitinib .&#xD;
&#xD;
          5. Has another primary tumor,but adequately treated non-melanoma skin cancer ,&#xD;
             effectively treated carcinoma in situ of cervix and other well handled cancer over 5&#xD;
             years were not covered.&#xD;
&#xD;
          6. Has difficulty in swallowing&#xD;
&#xD;
          7. Has taken experimental drugs within 14 days before randomly assign.( For different&#xD;
             drug characteristics, the interval can be longer)&#xD;
&#xD;
          8. History of any chemotherapy, radiotherapy,the last administration should finish within&#xD;
             3 weeks prior to trial first drug administration( For different drug characteristics,&#xD;
             the interval can be longer). If steady dose of diphosphate or denosumab is necessary&#xD;
             for the treatment of bone metastases,the administration should start 3-4weeks prior to&#xD;
             the study .&#xD;
&#xD;
          9. Patients with poor-controlled arterial hypertension (systolic blood pressure &gt; 140&#xD;
             mmHg or diastolic blood pressure &gt; 90 mm Hg) despite standard medical management;&#xD;
             Coronary heart disease greater than Class I, arrhythmia greater than Class I&#xD;
             (including QT interval prolongation, for man &gt; 450 ms, for woman &gt; 470 ms), and&#xD;
             cardiac dysfunction greater than Class I;&#xD;
&#xD;
         10. Has persistent toxicity (exclude alopecia )of previous treatment ,CTCAE&gt;1.&#xD;
&#xD;
         11. Has intestinal obstruction or upper gastrointestinal hemorrhage(CTCAE 3 or 4) within 4&#xD;
             weeks prior to randomly assign.&#xD;
&#xD;
         12. Abnormal coagulation function (INR &gt; 1.5×ULN, APTT &gt; 1.5×ULN), with tendency of bleed;&#xD;
&#xD;
         13. Has symptom of brain metastases and the tendency out of control,but imaging confirmed&#xD;
             is not required.If steady dose of Glucocorticoid is necessary for the treatment,the&#xD;
             administration should be started &gt;4weeks prior to the study . Patients with spinal&#xD;
             cord compression received definite treatment and the situation had been proven stable&#xD;
             in 28days .&#xD;
&#xD;
         14. Has surgery within 2 weeks prior to the study. Eligible patients should recovered from&#xD;
             any major surgery.&#xD;
&#xD;
         15. Subjects that are unable to swallow tablets, chronic diarrhea ,or intestinal&#xD;
             obstruction;&#xD;
&#xD;
         16. Subjects with a clear tendency of gastrointestinal bleeding;&#xD;
&#xD;
         17. Pregnant or lactating women;&#xD;
&#xD;
         18. Other conditions regimented at investigators' discretion.&#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>Haijun Zhong</last_name>
    <phone>0571-88122058</phone>
    <email>ZHJ1712@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</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/NCT03276156
org study id: Ahead-G001
nct id: NCT03276156
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the maximum tolerated dose (MTD)and safety of
      Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or
      gastroesophageal junction adenocarcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival(PFS)
time frame: Event driven, an expected average of 4 months
measure: Incidence of adverse events
time frame: An expected average of 4 months
measure: Overall survival(OS)
time frame: An expected average of 12months
measure: Disease control rate(DCR)
time frame: An expected average of 4 months
measure: Objective response rate(ORR)
time frame: An expected average of 4 months
measure: Quality of life(QoL)
time frame: An expected average of 12 months
arm group label: Apatinib plus S-1
arm group type: Experimental
description: Apatinib (425/500/675/750mg,qd,p.o.) concomitantly with S-1 (80mg to 120 mg, qd,days1-14, q3w, p.o.)
intervention type: Drug
intervention name: Apatinib plus S-1
description: Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);
arm group label: Apatinib plus S-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Haijun Zhong
phone: 0571-88122058
email: ZHJ1712@aliyun.com
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Apatinib