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/NCT05969899</url>
    </required_header>
    <id_info>
      <org_study_id>MA-CRC-II-008</org_study_id>
      <nct_id>NCT05969899</nct_id>
    </id_info>
    <brief_title>Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer</brief_title>
    <official_title>Prospective and Exploratory Study of Liposomal Irinotecan Based FOLFIRI Combined With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <has_dmc>No</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 goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan&#xD;
        liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is&#xD;
        Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival&#xD;
        (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on&#xD;
        NCI-CTCAE 5.0&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">February 10, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 10, 2024</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>Objective Response Rate（ORR）</measure>
      <time_frame>up to 2.5 years</time_frame>
      <description>The proportion of participants in the analyzed population who developed complete (CR) or partial response (PR) according to RECIST 1.1 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Survival（OS）</measure>
      <time_frame>up to 2.5 years</time_frame>
      <description>From the time of patient admission to the time of subject's death, at the end of the study, if the subject is still alive, the last known date of subject's survival is the deletion date</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival（PFS）</measure>
      <time_frame>up to 2.5 years</time_frame>
      <description>Time from patient admission to first radiographic disease progression (RECIST 1.1 criteria) or death (whichever occurs first)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate（DCR）</measure>
      <time_frame>up to 2.5 years</time_frame>
      <description>The proportion of subjects in the analyzed population who achieved CR, PR, or stable disease (SD) according to RECIST 1.1 criteria</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>FOLFIRI+BEV</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>FOLFIRI+Bevacizumab</intervention_name>
      <description>irinotecan liposome 60 mg/m2, iv, for at least 90 minutes LV 400 mg/m2, iv, for at least 2 hours FU 400 mg/m2, iv, followed by FU 2400 mg/m2, iv for at least 46 hours bevacizumab 5mg/kg IV. The above scenario is repeated every two weeks. Patients were treated until disease progression, toxic intolerance, initiation of a new antitumor therapy, withdrawal of knowledge, or investigator judgment that subjects should withdraw from study therapy.</description>
      <arm_group_label>FOLFIRI+BEV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provide written informed consent to participate in the study voluntarily.&#xD;
  &#xD;
            2. Male or female aged 18-75.&#xD;
  &#xD;
            3. Metastatic colorectal adenocarcinoma confirmed by histology or cytology.&#xD;
  &#xD;
            4. Have not received systematic anti-tumor therapy before; Patients who have received&#xD;
               neoadjuvant/adjuvant therapy may be screened from the time of last chemotherapy to&#xD;
               recurrence or progression more than 6 months.&#xD;
  &#xD;
            5. RAS/BRAF mutation status and UGT1A1*28/*6 gene polymorphism typing should be&#xD;
               determined before enrollment.&#xD;
  &#xD;
            6. The ECOG PS score is 0 or 1.&#xD;
  &#xD;
            7. Life expectancy is at least 3 months.&#xD;
  &#xD;
            8. According to RECIST 1.1, the investigators evaluated that there were measurable&#xD;
               lesions at baseline (according to RECIST 1.1), which could be measured if they had not&#xD;
               received local treatment such as radiotherapy (lesions located within the area of&#xD;
               previous radiotherapy could also be selected as target lesions if progression was&#xD;
               confirmed).&#xD;
  &#xD;
            9. The function of vital organs meets the following requirements (no blood component,&#xD;
               cell growth factor correction therapy drugs are allowed within 14 days before the&#xD;
               first use of the study drug);&#xD;
  &#xD;
                 1. Absolute neutrophil count (ANC) ≥1.5×109/L&#xD;
  &#xD;
                 2. Platelet ≥100×109/L;&#xD;
  &#xD;
                 3. Hemoglobin ≥9g/dL;&#xD;
  &#xD;
                 4. Serum albumin ≥2.5g/dL;&#xD;
  &#xD;
                 5. Total bilirubin ≤1.5 × ULN; ALT and AST≤2.5 × ULN, if there is liver metastasis,&#xD;
                    ALT and AST≤5 × ULN;&#xD;
  &#xD;
                 6. Serum creatinine ≤1.5 × ULN or creatinine clearance &gt; 60 mL/min&#xD;
                    (Cockcroft-Gault);&#xD;
  &#xD;
                 7. Activated partial thromboplastin time (APTT) and International Normalized ratio&#xD;
                    (INR) ≤1.5 × ULN (for stable dose anticoagulant therapy such as low molecular&#xD;
                    weight heparin or warfarin and INR within the intended therapeutic range of&#xD;
                    anticoagulants can be screened)&#xD;
  &#xD;
           10. Fertile female subjects are required to have a negative serum pregnancy test within 72&#xD;
               hours before the first dosing, are not breastfeeding, and use effective contraception&#xD;
               (such as Iuds, contraceptives, or condoms) during the trial period and for at least 6&#xD;
               months after the last dosing of the study drug; Male subjects whose partner is a&#xD;
               fertile woman should be surgically sterilized or agree to use effective contraception&#xD;
               during the trial period and within 3 months after the last dose of the study drug.&#xD;
               Sperm donation is not allowed during the study period;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Local radiotherapy was received within 4 weeks prior to the first administration of&#xD;
               the study drug, and adverse events due to radiotherapy have not returned to baseline&#xD;
               levels. Participants who received palliative radiotherapy for peripheral sites (such&#xD;
               as bone metastases) before 4 weeks may be admitted to the study, but must have&#xD;
               recovered from any acute adverse effects;&#xD;
  &#xD;
            2. Known active central nervous system (CNS) metastases and/or cancerous meningitis.&#xD;
               Participants who have previously received BMS may participate in treatment provided&#xD;
               they have stable BMS and have not been treated with steroids for BMS for at least 28&#xD;
               days prior to study start. This exception does not include cancerous meningitis, as&#xD;
               patients with cancerous meningitis are excluded regardless of clinical stability;&#xD;
  &#xD;
            3. Major surgery, open biopsy, or severe trauma occurred 28 days before the first&#xD;
               medication;&#xD;
  &#xD;
            4. Previous history of allergy to fluorouracil or irinotecan;&#xD;
  &#xD;
            5. Have high blood pressure that is not well controlled by antihypertensive medication&#xD;
               (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)&#xD;
  &#xD;
            6. Subjects have poorly controlled cardiovascular clinical symptoms or diseases,&#xD;
               including but not limited to:&#xD;
  &#xD;
          (1) NYHA grade II or above heart failure; (2) unstable angina pectoris; (3) myocardial&#xD;
          infarction within 1 year; (4) Clinically significant supraventricular or ventricular&#xD;
          arrhythmias that remain poorly controlled without or after clinical intervention.&#xD;
  &#xD;
          7. Clinically significant bleeding symptoms or definite bleeding tendency, such as&#xD;
          gastrointestinal bleeding, hemorrhagic ulcer or vasculitis, have occurred within 3 months&#xD;
          before the first medication.&#xD;
  &#xD;
          8. Arteriovenous thrombosis events occurring within 6 months before the first medication,&#xD;
          such as cerebrovascular accidents (including temporary ischemic attack, cerebral&#xD;
          hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.&#xD;
          Shallow vein thrombosis can be included after being determined by the researcher.&#xD;
  &#xD;
          9. There is another malignant tumor that is progressing or in need of aggressive treatment,&#xD;
          except for non-melanoma skin cancer and cervical cancer in situ for which potential&#xD;
          treatment has been performed.&#xD;
  &#xD;
          10. In the investigator's judgment, the subject has other factors that may lead to the&#xD;
          forced termination of the study, such as other serious medical conditions (including mental&#xD;
          illness) requiring co-treatment, serious abnormalities in laboratory test values, and&#xD;
          family or social factors that may affect the subject's safety or the circumstances in which&#xD;
          the trial data are collected.&#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>Xinxiang li, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Affiliated Cancer Hospital of Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xinxiang li, PhD</last_name>
      <phone>+8613761291659</phone>
      <email>1149lxx@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Affiliated Cancer Hospital of Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Pudong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xinxiang li, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>LI XIN-XIANG</investigator_full_name>
      <investigator_title>Head of the second ward of colorectal Surgery</investigator_title>
    </responsible_party>
    <keyword>irinotecan liposome</keyword>
    <keyword>FOLFIRI</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>Bevacizumab</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/NCT05969899
  org study id: MA-CRC-II-008
  nct id: NCT05969899
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan
        liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is
        Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival
        (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on
        NCI-CTCAE 5.0
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate（ORR）
  time frame: up to 2.5 years
  description: The proportion of participants in the analyzed population who developed complete (CR) or partial response (PR) according to RECIST 1.1 criteria
  measure: Overall Survival（OS）
  time frame: up to 2.5 years
  description: From the time of patient admission to the time of subject's death, at the end of the study, if the subject is still alive, the last known date of subject's survival is the deletion date
  measure: Progression Free Survival（PFS）
  time frame: up to 2.5 years
  description: Time from patient admission to first radiographic disease progression (RECIST 1.1 criteria) or death (whichever occurs first)
  measure: Disease Control Rate（DCR）
  time frame: up to 2.5 years
  description: The proportion of subjects in the analyzed population who achieved CR, PR, or stable disease (SD) according to RECIST 1.1 criteria
  arm group label: FOLFIRI+BEV
  arm group type: Other
  intervention type: Drug
  intervention name: FOLFIRI+Bevacizumab
  description: irinotecan liposome 60 mg/m2, iv, for at least 90 minutes LV 400 mg/m2, iv, for at least 2 hours FU 400 mg/m2, iv, followed by FU 2400 mg/m2, iv for at least 46 hours bevacizumab 5mg/kg IV. The above scenario is repeated every two weeks. Patients were treated until disease progression, toxic intolerance, initiation of a new antitumor therapy, withdrawal of knowledge, or investigator judgment that subjects should withdraw from study therapy.
  arm group label: FOLFIRI+BEV
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xinxiang li, PhD
  role: Principal Investigator
  affiliation: Affiliated Cancer Hospital of Fudan University
  last name: Xinxiang li, PhD
  phone: +8613761291659
  email: 1149lxx@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: LI XIN-XIANG
  investigator title: Head of the second ward of colorectal Surgery
  mesh term: Colorectal Neoplasms
  mesh term: Bevacizumab
  sharing ipd: No