<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/NCT04420130</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1210-HLJ-009</org_study_id>
    <nct_id>NCT04420130</nct_id>
  </id_info>
  <brief_title>A Trial of Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis（SHR-1210-HLJ-009）</brief_title>
  <official_title>Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis: a Single-arm, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yanqiao Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical University</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 a single-arm, prospective study of Camrelizumab combined with ablation and&#xD;
      chemotherapy for patients with Pancreatic cancer liver metastasis.&#xD;
&#xD;
      The main purpose of this study is to evaluate the safety and tolerability of Camrelizumab&#xD;
      combined with ablation and chemotherapy as a treatment of Pancreatic cancer liver metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Failed to pass ethics committee review&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</primary_completion_date>
  <phase>N/A</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>6-month PFS rate</measure>
    <time_frame>From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.</time_frame>
    <description>6-month progression-free survival rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>From the first drug administration up to two years</time_frame>
    <description>Overall Response Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>From the first drug administration up to two years</time_frame>
    <description>Disease Control Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>From the first drug administration up to two years</time_frame>
    <description>Progression Free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy</time_frame>
    <description>adverse events/serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Liver Metastasis</condition>
  <arm_group>
    <arm_group_label>Camrelizumab combined with ablation and chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, patients with liver metastases from pancreatic cancer are given ablation of liver metastases, and conventional chemotherapy plus camrelizumab is performed 1 week after surgery. If patients have multiple metastases, ablation treatment needs to be performed in stages, each ablation After 1 week of treatment, sequential chemotherapy + camrelizumab were reinfused, and the efficacy was evaluated every 2 cycles until the disease progressed or the patient could not tolerate it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Camrelizumab was administered 200mg iv every 3 weeks</description>
    <arm_group_label>Camrelizumab combined with ablation and chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>The chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer.</description>
    <arm_group_label>Camrelizumab combined with ablation and chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ablation</intervention_name>
    <description>First give pancreatic cancer patients with liver metastases to ablation of liver metastases</description>
    <arm_group_label>Camrelizumab combined with ablation and chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with liver metastasis of pancreatic cancer diagnosed by histology or&#xD;
             cytology;&#xD;
&#xD;
          -  Must have CT or MRI examination in the last 3 months;&#xD;
&#xD;
          -  With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);&#xD;
&#xD;
          -  Expected survival time&gt; 3 months;&#xD;
&#xD;
          -  The interval between the end of the patient's previous chemotherapy or adjuvant&#xD;
             chemotherapy must be more than 6 months;&#xD;
&#xD;
          -  No radiation therapy (unless there is at least one measurable target lesion in the&#xD;
             non-irradiated area);&#xD;
&#xD;
          -  Must score pain;&#xD;
&#xD;
          -  Age: 18 to 70 years old, male or female;&#xD;
&#xD;
          -  ECOG PS: 0-1 points;&#xD;
&#xD;
          -  The functions of important organs meet the following requirements:&#xD;
&#xD;
               1. Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9g/dL;&#xD;
&#xD;
               2. Bilirubin ≤ 1.5 times ULN (patients drained by retrograde technique may be&#xD;
                  included); ALT and AST ≤ 5 times ULN;&#xD;
&#xD;
               3. Creatinine &lt;120 μmol/L, or MDRD creatinine clearance rate&gt; 60 mL/min;&#xD;
&#xD;
          -  Women of childbearing age must undergo a negative pregnancy test (βHCG) before&#xD;
             starting treatment. Women and men of childbearing age (sexual relationships with women&#xD;
             of childbearing age) must agree to use them effectively during treatment and 6 months&#xD;
             after the last dose of treatment Contraceptive measures;&#xD;
&#xD;
          -  Signature of patient information and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or nursing, or have fertility but refuse to take contraceptive&#xD;
             measures;&#xD;
&#xD;
          -  During the enrollment period, a serious active infection requiring antibiotic&#xD;
             intravenous treatment occurred;&#xD;
&#xD;
          -  Those who are allergic to test drugs;&#xD;
&#xD;
          -  Presence of ≥2 grade neuropathy (CTCAE 5.0);&#xD;
&#xD;
          -  Uncontrolled, symptomatic brain metastases or those with a history of&#xD;
             difficult-to-control mental illness or severe intellectual or cognitive dysfunction;&#xD;
&#xD;
          -  Suffering from active, known or suspected autoimmune diseases (including but not&#xD;
             limited to: uveitis, enteritis, hepatitis, pituitary inflammation, nephritis,&#xD;
             vasculitis, hyperthyroidism, hypothyroidism and the need for bronchodilators Treatment&#xD;
             of asthma, etc.). Subjects with hypothyroidism who only need hormone replacement&#xD;
             therapy and skin diseases that do not require systemic treatment (such as vitiligo,&#xD;
             psoriasis, or hair loss) can be selected;&#xD;
&#xD;
          -  Have been vaccinated or will be vaccinated with live vaccine within 30 days before the&#xD;
             administration of Camrelizumab;&#xD;
&#xD;
          -  Congestive heart failure, uncontrolled arrhythmia, myocardial infarction, unstable&#xD;
             angina, stroke or transient ischemic attack within 6 months; or other patients who&#xD;
             cannot tolerate surgery;&#xD;
&#xD;
          -  Suffering from other malignant tumors within 5 years, except for fully treated&#xD;
             cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell&#xD;
             carcinoma of the skin that has been basically controlled;&#xD;
&#xD;
          -  Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;&#xD;
&#xD;
          -  The patient has already participated in another clinical trial;&#xD;
&#xD;
          -  People deprived of their liberty or guardianship;&#xD;
&#xD;
          -  Unable to receive medical supervision during the trial due to geographical, social or&#xD;
             psychological reasons;&#xD;
&#xD;
          -  Patients who cannot follow the trial protocol or cannot cooperate with follow-up;&#xD;
&#xD;
          -  The researchers believe that it is not appropriate to participate in this experiment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqiao Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harbin Medical University Cancer Hosptital</affiliation>
  </overall_official>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 1, 2022</last_update_submitted>
  <last_update_submitted_qc>October 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yanqiao Zhang</investigator_full_name>
    <investigator_title>Director of the hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04420130
org study id: SHR-1210-HLJ-009
nct id: NCT04420130
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a a single-arm, prospective study of Camrelizumab combined with ablation and
      chemotherapy for patients with Pancreatic cancer liver metastasis.

      The main purpose of this study is to evaluate the safety and tolerability of Camrelizumab
      combined with ablation and chemotherapy as a treatment of Pancreatic cancer liver metastasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 6-month PFS rate
time frame: From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
description: 6-month progression-free survival rate
measure: ORR
time frame: From the first drug administration up to two years
description: Overall Response Rate
measure: DCR
time frame: From the first drug administration up to two years
description: Disease Control Rate
measure: PFS
time frame: From the first drug administration up to two years
description: Progression Free Survival
measure: Incidence of Treatment-Emergent Adverse Events
time frame: from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy
description: adverse events/serious adverse events
arm group label: Camrelizumab combined with ablation and chemotherapy
arm group type: Experimental
description: First, patients with liver metastases from pancreatic cancer are given ablation of liver metastases, and conventional chemotherapy plus camrelizumab is performed 1 week after surgery. If patients have multiple metastases, ablation treatment needs to be performed in stages, each ablation After 1 week of treatment, sequential chemotherapy + camrelizumab were reinfused, and the efficacy was evaluated every 2 cycles until the disease progressed or the patient could not tolerate it.
intervention type: Drug
intervention name: Camrelizumab
description: Camrelizumab was administered 200mg iv every 3 weeks
arm group label: Camrelizumab combined with ablation and chemotherapy
intervention type: Drug
intervention name: Chemotherapy
description: The chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer.
arm group label: Camrelizumab combined with ablation and chemotherapy
intervention type: Procedure
intervention name: Ablation
description: First give pancreatic cancer patients with liver metastases to ablation of liver metastases
arm group label: Camrelizumab combined with ablation and chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yanqiao Zhang, PhD
role: Principal Investigator
affiliation: Harbin Medical University Cancer Hosptital
responsible party type: Sponsor-Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yanqiao Zhang
investigator title: Director of the hospital
mesh term: Neoplasm Metastasis
mesh term: Pancreatic Neoplasms
mesh term: Liver Neoplasms