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/NCT06022861</url>
    </required_header>
    <id_info>
      <org_study_id>LY01015/CT-CHN-302</org_study_id>
      <nct_id>NCT06022861</nct_id>
    </id_info>
    <brief_title>A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma</brief_title>
    <official_title>A Randomized, Double-blind, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of LY01015 and Opdivo®（Nivolumab Injection）Combined Respectively With Fluorouracil Plus Cisplatin in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong Boan Biotechnology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong Boan Biotechnology Co., Ltd</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>
        This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and&#xD;
        safety of LY01015 and Opdivo®（Nivolumab Injection）combined respectively with fluorouracil&#xD;
        plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously&#xD;
        untreated esophageal squamous cell carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective Response Rate(ORR) as assessed by IRC</measure>
      <time_frame>from baseline to week 16</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate(ORR) as assessed by IRC and investigator</measure>
      <time_frame>from baseline to week 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival (PFS)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>16-week Progression-Free Survival Rate</measure>
      <time_frame>from baseline to week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>24-week Progression-Free Survival Rate</measure>
      <time_frame>from baseline to week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse effects (AEs)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab)</measure>
      <time_frame>up to 2 years</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">510</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>LY01015+ Fluorouracil + Cisplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Opdivo® + Fluorouracil + Cisplatin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY01015</intervention_name>
      <description>Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period</description>
      <arm_group_label>LY01015+ Fluorouracil + Cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fluorouracil</intervention_name>
      <description>Intravenouslly (IV) l 800mg/m2 every 4 weeks (（on Day 1 through Day 5)during the combined chemotherapy period</description>
      <arm_group_label>LY01015+ Fluorouracil + Cisplatin</arm_group_label>
      <arm_group_label>Opdivo® + Fluorouracil + Cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period</description>
      <arm_group_label>LY01015+ Fluorouracil + Cisplatin</arm_group_label>
      <arm_group_label>Opdivo® + Fluorouracil + Cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Opdivo®</intervention_name>
      <description>Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, 480mg every 4 weeks(Q4W) during the maintenance treatment period within 24 weeks, thereafter converted to LY01015 480mg every 4 weeks(Q4W).</description>
      <arm_group_label>Opdivo® + Fluorouracil + Cisplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Willing to sign the informed consent form.&#xD;
  &#xD;
            2. Male or female aged 18 to 75 years patients.&#xD;
  &#xD;
            3. Histopathologically confirmed esophagus squamous cell carcinoma.&#xD;
  &#xD;
            4. Diagnosed with advanced or metastatic ESCC per AJCC 8th edition, not be amenable to&#xD;
               curative approaches( such as definitive chemoradiation/surgery), not received prior&#xD;
               systemic anti-cancer therapy for progressive or metastatic disease. Prior neoadjuvant,&#xD;
               adjuvant or definitive radiotherapy/chemoradiotherapy/chemotherapy for locally&#xD;
               advanced diseases is permitted if time from the last dose to recurrence&gt; 24 weeks.&#xD;
  &#xD;
            5. Must have at least one measurable lesion assessed by investigator per RECIST 1.1&#xD;
               criteria .&#xD;
  &#xD;
            6. ECOG performance status of 0 to 1.&#xD;
  &#xD;
            7. Prior to the first dose, the tumor tissue samples must be provided for PD-L1&#xD;
               expression analysis, and PD-L1 TPS≥1%.&#xD;
  &#xD;
            8. Expected survival ≥6 months.&#xD;
  &#xD;
            9. Adequate organ function at screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of symptomatic brain metastasis or spinal compression, or history of&#xD;
               meningeal metastasis. Patients with asymptomatic brain metastases who have received&#xD;
               prior treatment are permitted to enroll if the disease is stable, and corticosteroids&#xD;
               have not been required for at least 4 weeks prior to screening. Patients with&#xD;
               carcinomatous meningitis are ineligible, regardless of whether the disease is&#xD;
               clinically stable or not.&#xD;
  &#xD;
            2. With high risks of bleeding or fistula due to apparent tumor invasion to esophagus or&#xD;
               adjacent organs.&#xD;
  &#xD;
            3. Known endoscopy-confirmed near-complete obstruction requiring interventional therapy&#xD;
               or with risk of perforation post stent implantation in the esophagus or trachea.&#xD;
  &#xD;
            4. Unstable disease within 6 months prior to signing informed consent form, including but&#xD;
               not limited to unstable angina, myocardial infarction, NYHA Class II or higher cardiac&#xD;
               failure, severe arrhythmia or cerebrovascular accident (including transient ischemic&#xD;
               attacks) requiring treatment, or any other poorly-controlled systemic disease, for&#xD;
               example, uncontrolled hypertension (systolic pressure ≥160 mmHg or diastolic&#xD;
               pressure≥100 mmHg) despite standard treatment.&#xD;
  &#xD;
            5. Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or&#xD;
               anti-CTLA-4 agent or any other antibody or drug specifically targeting T-cell&#xD;
               co-stimulation or checkpoint pathways.&#xD;
  &#xD;
            6. Prior cumulative exposure dose of cisplatin&gt;300 mg/m2 and time from the last dose of&#xD;
               cisplatin to randomization ≤12 month.&#xD;
  &#xD;
            7. Received a live vaccine within 4 weeks prior to the first dose, or be scheduled to&#xD;
               receive a live vaccine during the entire course of the study.&#xD;
  &#xD;
            8. Received systemic chemotherapy, targeted therapy, immunosuppressants,&#xD;
               immunostimulants, biological agents, Chinese herbal medicines for anti-tumor&#xD;
               indications (prescription or medical record required), Chinese patent drug or any&#xD;
               other investigational agents or participated in interventional clinical study within 4&#xD;
               weeks (or five half-lives, whichever is longer) prior to the first dose.&#xD;
  &#xD;
            9. Other conditions, as determined by the investigator, for example, severe deep vein&#xD;
               thrombosis, arterial embolism, hepatic encephalopathy, Child-Pugh grade B or more&#xD;
               severe cirrhosis, or other acute or chronic disease, mental illnesses or laboratory&#xD;
               abnormalities, which may lead to the following consequences: increase the risks&#xD;
               associated with study participation or study drug administration, or interfere with&#xD;
               the interpretation of study results.&#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>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorouracil</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06022861
  org study id: LY01015/CT-CHN-302
  nct id: NCT06022861
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and
        safety of LY01015 and Opdivo®（Nivolumab Injection）combined respectively with fluorouracil
        plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously
        untreated esophageal squamous cell carcinoma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Objective Response Rate(ORR) as assessed by IRC
  time frame: from baseline to week 16
  measure: Objective Response Rate(ORR) as assessed by IRC and investigator
  time frame: from baseline to week 24
  measure: Disease Control Rate (DCR)
  time frame: up to 2 years
  measure: Duration of Response (DOR)
  time frame: up to 2 years
  measure: Progression-Free Survival (PFS)
  time frame: up to 2 years
  measure: 16-week Progression-Free Survival Rate
  time frame: from baseline to week 16
  measure: 24-week Progression-Free Survival Rate
  time frame: from baseline to week 16
  measure: Overall Survival (OS)
  time frame: up to 2 years
  measure: Incidence and severity of adverse effects (AEs)
  time frame: up to 2 years
  measure: Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab)
  time frame: up to 2 years
  arm group label: LY01015+ Fluorouracil + Cisplatin
  arm group type: Experimental
  arm group label: Opdivo® + Fluorouracil + Cisplatin
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: LY01015
  description: Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period
  arm group label: LY01015+ Fluorouracil + Cisplatin
  intervention type: Drug
  intervention name: Fluorouracil
  description: Intravenouslly (IV) l 800mg/m2 every 4 weeks (（on Day 1 through Day 5)during the combined chemotherapy period
  arm group label: LY01015+ Fluorouracil + Cisplatin
  arm group label: Opdivo® + Fluorouracil + Cisplatin
  intervention type: Drug
  intervention name: Cisplatin
  description: Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period
  arm group label: LY01015+ Fluorouracil + Cisplatin
  arm group label: Opdivo® + Fluorouracil + Cisplatin
  intervention type: Drug
  intervention name: Opdivo®
  description: Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, 480mg every 4 weeks(Q4W) during the maintenance treatment period within 24 weeks, thereafter converted to LY01015 480mg every 4 weeks(Q4W).
  arm group label: Opdivo® + Fluorouracil + Cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Fluorouracil