<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/NCT03228043</url>
  </required_header>
  <id_info>
    <org_study_id>Apatinib in Colorectal Surgery</org_study_id>
    <nct_id>NCT03228043</nct_id>
  </id_info>
  <brief_title>Apatinib for Resectable Colorectal Cancer</brief_title>
  <official_title>Apatinib With Postoperative Adjuvant Chemotherapy for Operable Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanchong Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanchong Central 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>
      Objective: To compare the outcome of patients with colorectal cancer who treated with&#xD;
      adjuvant therapy or Apatinib with adjuvant therapy postoperatively.&#xD;
&#xD;
      Language: English.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    It's not possible to complete in our hospital.&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>N/A</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants recurrence-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants recurrence-free survival in intervention group and control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants overall survival in intervention group and control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants recurrence-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Number of Participants recurrence-free survival in intervention group and control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>Number of Participants overall survival in intervention group and control group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants recurrence-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Number of Participants recurrence-free survival in intervention group and control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Number of Participants overall survival in intervention group and control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants recurrence-free survival</measure>
    <time_frame>4 years</time_frame>
    <description>Number of Participants recurrence-free survival in intervention group and control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants overall survival</measure>
    <time_frame>4 years</time_frame>
    <description>Number of Participants overall survival in intervention group and control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants recurrence-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Number of Participants recurrence-free survival in intervention group and control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>Number of Participants overall survival in intervention group and control group.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Apatinib</condition>
  <condition>Outcome, Fatal</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Surgery</condition>
  <condition>Adjuvant Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Apatinib group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib combined with CAPEOX program. Apatinib tablets: 500 mg po qd from the second cycle of chemotherapy. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>CAPEOX program. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal</description>
    <arm_group_label>Apatinib group</arm_group_label>
    <other_name>YN968D1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAPEOX</intervention_name>
    <description>CAPEOX adjuvant chemotherapy for resectable colorectal</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>adjuvant chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ECOG performance status score: 0-1.&#xD;
&#xD;
          2. All colorectal cancer patients underwent curative intent surgery&#xD;
&#xD;
          3. Patients in stage Ⅱ(Any T, N0, M0) with multiple high-risk factors or stage Ⅲ (any T,&#xD;
             N1-2, M0) which confirmed by pathology.&#xD;
&#xD;
          4. Patients who did not receive other treatments for colorectal adenocarcinoma after&#xD;
             surgery;&#xD;
&#xD;
          5. The main organ function is good, patients must meet the following requirements with 14&#xD;
             days before using Apatinib:&#xD;
&#xD;
               -  blood routine examination:&#xD;
&#xD;
                    -  hemoglobin&gt; 90 g / L (14 days without blood transfusion);&#xD;
&#xD;
                    -  neutrophil count&gt; 1.5 x 109 / L;&#xD;
&#xD;
                    -  platelet count&gt; 100 × 109 / L;&#xD;
&#xD;
               -  biochemical examination:&#xD;
&#xD;
                    -  total bilirubin ≤ 1.5 × ULN (normal upper limit);&#xD;
&#xD;
                    -  alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2 ×&#xD;
                       ULN;&#xD;
&#xD;
                    -  Endogenous creatinine clearance ≥ 60 ml / min (Cockcroft-Gault formula);&#xD;
&#xD;
               -  Cardiac Doppler Ultrasonography: Left ventricular ejection fraction (LVEF) ≥ 50%.&#xD;
&#xD;
          6. The surgical incision has been healed, and no bleeding tendency;&#xD;
&#xD;
          7. Sign informed consent;&#xD;
&#xD;
          8. Compliance is good, family members agreed to accept survival follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with other malignancies, except for cured skin basal cell carcinoma and&#xD;
             cervical cancer in situ.&#xD;
&#xD;
          2. Participated in other drug clinical trials within four weeks.&#xD;
&#xD;
          3. Have a variety of factors that affect oral medication (such as unable to swallow,&#xD;
             chronic diarrhea and intestinal obstruction, etc.).&#xD;
&#xD;
          4. Have a history of bleeding, screening within 4 weeks before any serious grade to&#xD;
             CTCAE4.0 3 degrees or more bleeding events.&#xD;
&#xD;
          5. Patients with central nervous system metastases or a history of central nervous system&#xD;
             metastases before screening. For patients with suspected central nervous system&#xD;
             metastases, CT or MRI examinations must be performed within 28 days prior to&#xD;
             randomization to exclude central nervous system metastasis.&#xD;
&#xD;
          6. History of high blood pressure can not be controlled with a single antihypertensive&#xD;
             drug therapy (With a systolic blood pressure&gt; 140 mmHg, diastolic blood pressure&gt; 90&#xD;
             mmHg. A history of unstable angina within 3 months or a new diagnosis of angina within&#xD;
             6 months (Including QTcF: male ≥ 450 ms, female ≥470 ms) required long-term use of&#xD;
             antiarrhythmic drugs and New York Heart Association classification ≥ Class II cardiac&#xD;
             insufficiency.&#xD;
&#xD;
          7. Urinary protein ≥ ++ and urine protein&gt; 1.0 g in 24 hours.&#xD;
&#xD;
          8. Patients with anastomotic fistula, pancreatic fistula or anastomotic stenosis and&#xD;
             other serious postoperative complications.&#xD;
&#xD;
          9. Long-term non-healing wounds or bone fractures.&#xD;
&#xD;
         10. history of organ transplantation.&#xD;
&#xD;
         11. Imaging shows that the tumor has involved important vascular. Patients in high risk of&#xD;
             fatal bleeding during treatment.&#xD;
&#xD;
         12. coagulation abnormalities, with bleeding tendency (14 days before randomization must&#xD;
             meet: in the absence of anticoagulants, INR in normal range). application of&#xD;
             anticoagulants or vitamin K antagonists such as warfarin, (1 mg orally, once daily) or&#xD;
             low-dose aspirin (1 mg or less daily) at a prokaryotic time (INR) ≤ 1.5 Daily&#xD;
             consumption of not more than 100 mg).&#xD;
&#xD;
         13. During the last year, the history of tachycardia / venous thrombosis events, such as&#xD;
             cerebrovascular accident (including transient ischemic attack), deep venous thrombosis&#xD;
             (due to pre-chemotherapy intravenous thrombosis caused by intravenous thrombosis which&#xD;
             have been cured ) And pulmonary embolism.&#xD;
&#xD;
         14. previous thyroid dysfunction, thyroid function can not be maintained within the normal&#xD;
             range during medication.&#xD;
&#xD;
         15. with a history of psychiatric drug abuse and can not be prevented or have mental&#xD;
             disorders.&#xD;
&#xD;
         16. Have a history of immunodeficiency, or suffer from other acquired, congenital&#xD;
             immunodeficiency disease, or organ transplant history.&#xD;
&#xD;
         17. According to the researcher's judgment, there is a serious risk of compromising the&#xD;
             patient's safety or affecting the patient's completion of the study.&#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>Yunhong Tian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanchong Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yunhong Tian</name>
      <address>
        <city>Nanchong</city>
        <state>Sichuan</state>
        <zip>637000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>April 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>January 31, 2020</last_update_submitted>
  <last_update_submitted_qc>January 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanchong Central Hospital</investigator_affiliation>
    <investigator_full_name>Yunhong Tian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Apatinib</keyword>
  <keyword>Outcome, Fatal</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>surgery</keyword>
  <keyword>adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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>
  <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/NCT03228043
org study id: Apatinib in Colorectal Surgery
nct id: NCT03228043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To compare the outcome of patients with colorectal cancer who treated with
      adjuvant therapy or Apatinib with adjuvant therapy postoperatively.

      Language: English.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants recurrence-free survival
time frame: 1 year
description: Number of Participants recurrence-free survival in intervention group and control group.
measure: Number of Participants overall survival
time frame: 1 year
description: Number of Participants overall survival in intervention group and control group.
measure: Number of Participants recurrence-free survival
time frame: 2 years
description: Number of Participants recurrence-free survival in intervention group and control group.
measure: Number of Participants overall survival
time frame: 2 years
description: Number of Participants overall survival in intervention group and control group.
measure: Number of Participants recurrence-free survival
time frame: 3 years
description: Number of Participants recurrence-free survival in intervention group and control group.
measure: Number of Participants overall survival
time frame: 3 years
description: Number of Participants overall survival in intervention group and control group.
measure: Number of Participants recurrence-free survival
time frame: 4 years
description: Number of Participants recurrence-free survival in intervention group and control group.
measure: Number of Participants overall survival
time frame: 4 years
description: Number of Participants overall survival in intervention group and control group.
measure: Number of Participants recurrence-free survival
time frame: 5 years
description: Number of Participants recurrence-free survival in intervention group and control group.
measure: Number of Participants overall survival
time frame: 5 years
description: Number of Participants overall survival in intervention group and control group.
arm group label: Apatinib group
arm group type: Experimental
description: Apatinib combined with CAPEOX program. Apatinib tablets: 500 mg po qd from the second cycle of chemotherapy. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.
arm group label: Control group
arm group type: Placebo Comparator
description: CAPEOX program. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.
intervention type: Drug
intervention name: Apatinib
description: Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal
arm group label: Apatinib group
other name: YN968D1
intervention type: Drug
intervention name: CAPEOX
description: CAPEOX adjuvant chemotherapy for resectable colorectal
arm group label: Control group
other name: adjuvant chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yunhong Tian
role: Principal Investigator
affiliation: Nanchong Central Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanchong Central Hospital
investigator full name: Yunhong Tian
investigator title: Principal Investigator
mesh term: Colorectal Neoplasms
mesh term: Apatinib
sharing ipd: No