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/NCT06009029</url>
    </required_header>
    <id_info>
      <org_study_id>SPARK-1</org_study_id>
      <nct_id>NCT06009029</nct_id>
    </id_info>
    <brief_title>SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)</brief_title>
    <official_title>A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</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>
        This trial is designed to investigate the efficacy and safety of patients with locally&#xD;
        advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This a prospective, single-arm, multicenter study evaluating the efficacy and safety of&#xD;
        stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic&#xD;
        cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2026</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>Overall survival (OS)</measure>
      <time_frame>2 years</time_frame>
      <description>Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>2 years</time_frame>
      <description>Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>2 years</time_frame>
      <description>Disease control rate will be defined as PR +CR rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>2 years</time_frame>
      <description>Disease control rate will be defined as objective response rate + steady disease rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>2 years</time_frame>
      <description>Based on NCI-CTC AE v5.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Locally Advanced Pancreatic Cancer</condition>
    <arm_group>
      <arm_group_label>SBRT Combined With Zimberelimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Stereotactic body radiation(SBRT)</intervention_name>
      <description>SBRT: 7-10 Gy/F, 5 doses&#xD;
  Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.</description>
      <arm_group_label>SBRT Combined With Zimberelimab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Zimberelimab (GLS-010)</intervention_name>
      <description>Zimberelimab (GLS-010),240mg d1 iv Q21D</description>
      <arm_group_label>SBRT Combined With Zimberelimab</arm_group_label>
      <other_name>Immunotherapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-75 years old.&#xD;
  &#xD;
            -  Locally advanced pancreatic cancer confirmed histologically and defined according to&#xD;
               the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.&#xD;
  &#xD;
            -  The expected survival ≥ 3 months.&#xD;
  &#xD;
            -  At least one tumor lesion meeting measurable disease criteria as determined by RECIST&#xD;
               v1.1.&#xD;
  &#xD;
            -  Patient must have adequate organ function defined by the study-specified laboratory&#xD;
               tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph&#xD;
               node metastasis invading the gastrointestinal parenchyma.&#xD;
  &#xD;
            -  Woman who are pregnant or breastfeeding.&#xD;
  &#xD;
            -  Has a known additional malignancy within the past 5 years, except for cured skin&#xD;
               cancer and cervical carcinoma in situ.&#xD;
  &#xD;
            -  Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,&#xD;
               anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell&#xD;
               receptor.&#xD;
  &#xD;
            -  Contraindications to immunotherapy.&#xD;
  &#xD;
            -  Other conditions that investigator decides not suitable for the trial.&#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>Junjie Wang, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Junjie Wang, M.D.</last_name>
      <phone>+8613701076310</phone>
      <email>wangjunjie_puth@163.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Locally Advanced Pancreatic Cancer</keyword>
    <keyword>SBRT</keyword>
    <keyword>Zimberelimab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</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/NCT06009029
  org study id: SPARK-1
  nct id: NCT06009029
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This trial is designed to investigate the efficacy and safety of patients with locally
        advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
  This a prospective, single-arm, multicenter study evaluating the efficacy and safety of
        stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic
        cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall survival (OS)
  time frame: 2 years
  description: Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.
  measure: Progression-free survival (PFS)
  time frame: 2 years
  description: Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
  measure: Objective response rate (ORR)
  time frame: 2 years
  description: Disease control rate will be defined as PR +CR rate.
  measure: Disease Control Rate (DCR)
  time frame: 2 years
  description: Disease control rate will be defined as objective response rate + steady disease rate.
  measure: Adverse Events
  time frame: 2 years
  description: Based on NCI-CTC AE v5.0
  arm group label: SBRT Combined With Zimberelimab
  arm group type: Experimental
  description: Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
  intervention type: Radiation
  intervention name: Stereotactic body radiation(SBRT)
  description: SBRT: 7-10 Gy/F, 5 doses
  Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.
  arm group label: SBRT Combined With Zimberelimab
  intervention type: Drug
  intervention name: Zimberelimab (GLS-010)
  description: Zimberelimab (GLS-010),240mg d1 iv Q21D
  arm group label: SBRT Combined With Zimberelimab
  other name: Immunotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Junjie Wang, M.D.
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Junjie Wang, M.D.
  phone: +8613701076310
  email: wangjunjie_puth@163.com
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  mesh term: Immunomodulating Agents
  sharing ipd: No