<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/NCT03255811</url>
  </required_header>
  <id_info>
    <org_study_id>Gastrointestinal cancer</org_study_id>
    <nct_id>NCT03255811</nct_id>
  </id_info>
  <brief_title>Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer</brief_title>
  <official_title>Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer -- Multicenter, Open, One Arm Exploratory Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DongMa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, apatinib was approved for the treatment of advanced gastric cancer after&#xD;
      second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of&#xD;
      medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small&#xD;
      sample exploratory research, in the conventional chemotherapy after the onset, with APA for&#xD;
      Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line&#xD;
      advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the&#xD;
      feasibility of anti generate small molecule targeted therapy in advanced gastric cancer&#xD;
      vascular pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of gastric cancer in China is high, and there is no standard first-line&#xD;
      chemotherapy regimen for advanced gastric cancer. Second-line therapy usually involves&#xD;
      first-line treatment, without the use of drugs for combination or monotherapy, and no uniform&#xD;
      treatment. Apatinib approved provides a good solution to this problem, but this study is in&#xD;
      limit of validity standard after all into the row, not very good reaction in clinical&#xD;
      practice for APA imatinib reality in the treatment of advanced gastric cancer. Therefore, it&#xD;
      is necessary to make a prospective product study to understand the gap between clinical&#xD;
      practice and research results. This study can evaluate apatinib in treatment of advanced&#xD;
      gastric or gastroesophageal junction safe and effective parts of adenocarcinoma in clinical&#xD;
      practice, and the specific usage (such as dose and period). The results of this study can&#xD;
      help the future clinical practice specification of apatinib parts for the treatment of&#xD;
      adenocarcinoma with advanced gastric or gastroesophageal reflux, the advanced gastric or&#xD;
      gastroesophageal adenocarcinoma patients with parts get treatment more safe and effective in&#xD;
      the treatment of.&#xD;
&#xD;
      At present, apatinib was approved for the treatment of advanced gastric cancer after&#xD;
      second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of&#xD;
      medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small&#xD;
      sample exploratory research, in the conventional chemotherapy after the onset, with APA for&#xD;
      Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line&#xD;
      advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the&#xD;
      feasibility of anti generate small molecule targeted therapy in advanced gastric cancer&#xD;
      vascular pattern.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 25, 2017</start_date>
  <completion_date type="Anticipated">March 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 25, 2019</primary_completion_date>
  <phase>N/A</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>At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma</measure>
    <time_frame>2 years</time_frame>
    <description>Progression free survival</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Advanced Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>The dosage regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The chemotherapy response rate reached the maximum after 14-28 days, apatinib, 750 mg (QD), once a day, half an hour after meal (daily dosing time should be as same as possible), with warm boiling water delivery service. 28 days for a dosing cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>apatinib</intervention_name>
    <description>Apatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival.</description>
    <arm_group_label>The dosage regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age: more than 18 years old, male or female;&#xD;
&#xD;
          2. histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma,&#xD;
             stomach with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST&#xD;
             standard 1.1);&#xD;
&#xD;
          3. inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or&#xD;
             esophagogastric junction;&#xD;
&#xD;
          4. first-line chemotherapy (oxaliplatin / cisplatin / paclitaxel combined with&#xD;
             fluorouracil / either drug, docetaxel or S-1 / capecitabine), efficacy evaluation of&#xD;
             SD or CR or PR may, from the last chemotherapy cycle time is not more than 28 days;&#xD;
&#xD;
          5. when evaluating the maximum response rate of chemotherapy (chemotherapy is not less&#xD;
             than 4 cycles), enter maintenance therapy. (maximum response rate: compared with the&#xD;
             previous curative effect evaluation, the target lesion no longer continued to shrink);&#xD;
&#xD;
          6. ECOG PS:0-1 points;&#xD;
&#xD;
          7. baseline blood routine and biochemical parameters met the following criteria:&#xD;
             Hemoglobin is larger than 80g/L,&#xD;
&#xD;
               -  the absolute neutrophil count (ANC) = 1.5 * 109/L, Over 90 * 109/L platelets,&#xD;
&#xD;
               -  ALT, AST less than 2.5 times the upper limit of normal value, Equal to or less&#xD;
                  than 5 times the upper limit of normal (liver metastasis),&#xD;
&#xD;
               -  the serum total bilirubin is less than 1.5 times the upper limit of normal value,&#xD;
                  Serum creatinine. Less than 1.5 times the upper limit of normal value, Serum&#xD;
                  albumin is more than 30g/L;&#xD;
&#xD;
          8. more than the expected survival time in March;&#xD;
&#xD;
          9. women of childbearing age must have pregnancy tests (serum or urine) within 7 days&#xD;
             prior to admission, and the results are negative and are willing to take the&#xD;
             appropriate method of contraception at 8 weeks after the trial and at the end of the&#xD;
             test. For men, surgical sterilization should be applied, or consent to the appropriate&#xD;
             method of contraception 8 weeks after the trial and at the end of the trial;&#xD;
&#xD;
         10. subjects voluntarily joined the study, signed informed consent, good compliance, and&#xD;
             followed up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. confirmed of apatinib and / or its accessories allergy;&#xD;
&#xD;
          2. with high blood pressure and the antihypertensive drug treatment can not be reduced to&#xD;
             the normal range (&gt;140 systolic blood pressure mmHg, diastolic blood pressure &gt;90&#xD;
             mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc&#xD;
             prolongation &gt; 450 male MS, female MS &gt; 470) and grade I heart function insufficiency;&#xD;
             patients with positive urinary protein;&#xD;
&#xD;
          3. , there are a variety of factors that affect oral medication (such as inability to&#xD;
             swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); The 4. has a&#xD;
             clear tendency in patients with gastrointestinal bleeding, including the following:&#xD;
             local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2&#xD;
             months melena, hematemesis history; for fecal occult blood (+) and gastric primary&#xD;
             tumor without surgical resection. And for gastroscopy, such as gastric cancer, and&#xD;
             researchers believe that may occur in massive hemorrhage of digestive tract were;&#xD;
&#xD;
        5. coagulation dysfunction (INR&gt;1.5, APTT&gt;1.5, ULN), with bleeding tendency; 6. patients&#xD;
        with central nervous system metastasis; 7. pregnant or lactating women; A patient with&#xD;
        other malignancies within 8.5 years; 9. patients who have history of psychotropic substance&#xD;
        abuse and are unable to quit or have mental disorders; Patients who participated in other&#xD;
        clinical trials within 10.4 weeks; 11. received VEGFR inhibitors, such as Sola Fini and&#xD;
        sunitinib therapy; 12. according to the researcher's judgment, there are patients who&#xD;
        seriously endanger the safety of patients or affect the patients who complete the study;&#xD;
        13., the researchers considered unsuitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ma Dong, graduate</last_name>
    <role>Study Director</role>
    <affiliation>Leading Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>DongMa</investigator_full_name>
    <investigator_title>Director of gastrointestinal oncology</investigator_title>
  </responsible_party>
  <keyword>Advanced gastric cancer apatinib Maintenance therapy</keyword>
  <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/NCT03255811
org study id: Gastrointestinal cancer
nct id: NCT03255811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
At present, apatinib was approved for the treatment of advanced gastric cancer after
      second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of
      medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small
      sample exploratory research, in the conventional chemotherapy after the onset, with APA for
      Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line
      advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the
      feasibility of anti generate small molecule targeted therapy in advanced gastric cancer
      vascular pattern.
The incidence of gastric cancer in China is high, and there is no standard first-line
      chemotherapy regimen for advanced gastric cancer. Second-line therapy usually involves
      first-line treatment, without the use of drugs for combination or monotherapy, and no uniform
      treatment. Apatinib approved provides a good solution to this problem, but this study is in
      limit of validity standard after all into the row, not very good reaction in clinical
      practice for APA imatinib reality in the treatment of advanced gastric cancer. Therefore, it
      is necessary to make a prospective product study to understand the gap between clinical
      practice and research results. This study can evaluate apatinib in treatment of advanced
      gastric or gastroesophageal junction safe and effective parts of adenocarcinoma in clinical
      practice, and the specific usage (such as dose and period). The results of this study can
      help the future clinical practice specification of apatinib parts for the treatment of
      adenocarcinoma with advanced gastric or gastroesophageal reflux, the advanced gastric or
      gastroesophageal adenocarcinoma patients with parts get treatment more safe and effective in
      the treatment of.

      At present, apatinib was approved for the treatment of advanced gastric cancer after
      second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of
      medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small
      sample exploratory research, in the conventional chemotherapy after the onset, with APA for
      Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line
      advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the
      feasibility of anti generate small molecule targeted therapy in advanced gastric cancer
      vascular pattern.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma
time frame: 2 years
description: Progression free survival
arm group label: The dosage regimen
arm group type: Experimental
description: The chemotherapy response rate reached the maximum after 14-28 days, apatinib, 750 mg (QD), once a day, half an hour after meal (daily dosing time should be as same as possible), with warm boiling water delivery service. 28 days for a dosing cycle.
intervention type: Drug
intervention name: apatinib
description: Apatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival.
arm group label: The dosage regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ma Dong, graduate
role: Study Director
affiliation: Leading Investigator
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: DongMa
investigator title: Director of gastrointestinal oncology
mesh term: Stomach Neoplasms
mesh term: Apatinib