xml: <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/NCT06014944</url>
    </required_header>
    <id_info>
      <org_study_id>CHoicelll</org_study_id>
      <nct_id>NCT06014944</nct_id>
    </id_info>
    <brief_title>Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody</brief_title>
    <acronym>PMMR/MSS</acronym>
    <official_title>A Single-arm, Single-center, Prospective Clinical Study of Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody for Neoadjuvant Therapy of PMMR/MSS Type Middle and Low Locally Advanced Rectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai 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>
        The investigators conduct a single-arm, single-center, prospective clinical study enrolling&#xD;
        patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had&#xD;
        not received systemic anti-tumor therapy to explore the efficacy and safety of short-course&#xD;
        radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>cCR rate</measure>
      <time_frame>5 years</time_frame>
      <description>the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radiotherapy 5 * 5 Gy, once a day, 5 Gy each time, for 5 days.Two weeks after the end of radiotherapy, the patients were treated with furoquintinib combined with slurimab, furoquintinib 5 mg / time / day, d1-14, Q3 W ; combined with 300 mg of brucella, intravenous injection, d1, Q3W ; a total of 4 cycles of treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody</intervention_name>
      <description>neoadjuvant therapy for short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody for PMMR / MSS type middle and low locally advanced rectal cancer.</description>
      <arm_group_label>Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. This study has been fully understood and voluntarily signed informed consent ;&#xD;
  &#xD;
            2. Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was&#xD;
               histologically confirmed as pMMR / MSS type ( according to the detection criteria of&#xD;
               the institutional testing center, it can be detected by immunohistochemistry, PCR or&#xD;
               NGS ), and was staged as stage II ( T3-4N0 ) or stage III ( T1-4N1-2 ) by MRI and CT.&#xD;
  &#xD;
          4.MRI was used to evaluate the middle and low rectal cancer below 10 cm from the anal&#xD;
          margin of the tumor ; 5.Patients who were recommended for neoadjuvant therapy after&#xD;
          evaluation by the Multidisciplinary Oncology Committee ; 6.ECOG physical condition 0-1&#xD;
          points ; 7.Expected survival ≥ 2 years ; 8.No previous anti-tumor treatment has been&#xD;
          received ; the function of vital organs meets the following requirements ( not allowed to&#xD;
          use any blood components and cell growth factors within * 14 days before enrollment ) :&#xD;
          Absolute neutrophil count ≥ 1.5 × 109 / L ; platelet ≥ 100 × 109 / L ; hemoglobin ≥ 90g / L&#xD;
          ; total bilirubin &lt; 1.5 times ULN ; aLT and / or AST &lt; 2.5 times ULN ; serum creatinine &lt;&#xD;
          1.5 times ULN ; endogenous creatinine clearance rate ≥ 50ml / min ; 10. Women of&#xD;
          childbearing age need to take effective contraceptive measures ; 11.good compliance, with&#xD;
          follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1.Unable to comply with the research program or research procedures ; 2.Patients with&#xD;
               surgical taboos ; 3.Patients with metastatic disease or recurrent rectal cancer ;&#xD;
               4.Patients with familial adenomatous polyposis ( FAP ), hereditary nonpolyposis&#xD;
               colorectal cancer ( HNPCC ), active Crohn 's disease or active ulcerative colitis ;&#xD;
               5.Patients with other malignant tumors within 5 years before enrollment, except for&#xD;
               basal cell or squamous cell carcinoma of the skin after radical resection, or cervical&#xD;
               carcinoma in situ ; 6.Severe cardiovascular diseases, including unstable angina or&#xD;
               myocardial infarction, occurred within 6 months before enrollment ; 7.Subjects who&#xD;
               were allergic to the study drug or any of its adjuvants ; 8.Participated in other&#xD;
               domestic unapproved or unlisted drug clinical trials within 4 weeks before enrollment&#xD;
               and received corresponding experimental drug treatment ; 9.International normalized&#xD;
               ratio ( INR ) &gt; 1.5 or activated partial thromboplastin time ( APTT ) &gt; 1.5 × ULN ;&#xD;
               10.Investigators judged clinically significant electrolyte abnormalities ; 11.There&#xD;
               was uncontrolled hypertension before enrollment, which was defined as : systolic blood&#xD;
               pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg ; 12.There were poorly&#xD;
               controlled diabetes before enrollment ( after regular treatment, fasting glucose&#xD;
               concentration ≥ CTCAE grade 2 ) ; 1.3.13.Before enrollment, there are any diseases or&#xD;
               states that affect drug absorption, or patients cannot take oral drugs ; 14.Before&#xD;
               entering the group, there were gastrointestinal diseases such as gastric and duodenal&#xD;
               active ulcers and ulcerative colitis, or other conditions that may cause&#xD;
               gastrointestinal bleeding and perforation determined by the researchers ; 15.Severe&#xD;
               active bleeding, hemoptysis ( fresh blood &gt; 5 mL within 4 weeks ) or thromboembolic&#xD;
               events occurred within 12 months before enrollment ( package ).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhai Hospital</investigator_affiliation>
      <investigator_full_name>Wei Zhang</investigator_full_name>
      <investigator_title>Director of the department of colorectal surgery</investigator_title>
    </responsible_party>
    <keyword>short course radiotherapy</keyword>
    <keyword>furoquintinib</keyword>
    <keyword>PD-1</keyword>
    <keyword>low locally advanced rectal cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014944
  org study id: CHoicelll
  nct id: NCT06014944
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The investigators conduct a single-arm, single-center, prospective clinical study enrolling
        patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had
        not received systemic anti-tumor therapy to explore the efficacy and safety of short-course
        radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: cCR rate
  time frame: 5 years
  description: the clinical complete remission rate of short-course radiotherapy followed by sequential fruquintinib combined with PD1 monoantibody therapy for locally advanced rectal cancer.
  arm group label: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
  arm group type: Experimental
  description: Radiotherapy 5 * 5 Gy, once a day, 5 Gy each time, for 5 days.Two weeks after the end of radiotherapy, the patients were treated with furoquintinib combined with slurimab, furoquintinib 5 mg / time / day, d1-14, Q3 W ; combined with 300 mg of brucella, intravenous injection, d1, Q3W ; a total of 4 cycles of treatment.
  intervention type: Drug
  intervention name: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
  description: neoadjuvant therapy for short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody for PMMR / MSS type middle and low locally advanced rectal cancer.
  arm group label: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Changhai Hospital
  investigator full name: Wei Zhang
  investigator title: Director of the department of colorectal surgery
  mesh term: Rectal Neoplasms
  mesh term: Antibodies
  mesh term: Antibodies, Monoclonal
  sharing ipd: No