<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/NCT04498689</url>
  </required_header>
  <id_info>
    <org_study_id>CSPAC-27</org_study_id>
    <nct_id>NCT04498689</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Camrelizumab Combined With Nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer</brief_title>
  <official_title>A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of PD-1 Antibody Camrelizumab in Combination With Nab-paclitaxel Plus Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan 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>
      The present study is intended to investigate the objective response rate (ORR) and the&#xD;
      progression-free survival (PFS) of the patients with histologically- or&#xD;
      cytologically-confirmed metastatic pancreatic cancer after treating with the combination of&#xD;
      camrelizumab, gemcitabine and nab-paclitaxel, and to investigate the overall survival (OS)&#xD;
      and the adverse event (AE) of the patients with histologically- or cytologically-confirmed&#xD;
      metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine&#xD;
      and nab-paclitaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a prospective, single-arm, open-label, phase 2 studye evaluating the efficacy and safety&#xD;
      of camrelizumab, gemcitabine and nab-paclitaxel for metastatic pancreatic cancer patients.&#xD;
      The primary endpoints are ORR and PFS, and the secondary are OS and adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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 Response Rate</measure>
    <time_frame>from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months</time_frame>
    <description>To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months</time_frame>
    <description>To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months</time_frame>
    <description>To evaluate the overall survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months</time_frame>
    <description>To evaluate the adverse events of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">117</enrollment>
  <condition>Metastatic Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>camrelizumab + nab-paclitaxel + gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PD-1 Monoclonal Antibody Camrelizumab at 200 mg on Day 1 and 15 nab-paclitaxel at 100 mg/m2 on Day 1, 8, and 15; gemcitabine at 1000 mg/m2 on Day 1, 8, and 15</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Patients firstly receive camrelizumab 200 mg per time (iv, no less than 20 minutes and no more than 60 minutes, rinse time included) on Day 1 and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.</description>
    <arm_group_label>camrelizumab + nab-paclitaxel + gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab paclitaxel</intervention_name>
    <description>Patients secondly receive nab-paclitaxel 100 mg/m2 (iv, at least 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.</description>
    <arm_group_label>camrelizumab + nab-paclitaxel + gemcitabine</arm_group_label>
    <other_name>Albumin paclitaxl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine Injection</intervention_name>
    <description>At last, patients receive gemcitabine 1000 mg/m2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.</description>
    <arm_group_label>camrelizumab + nab-paclitaxel + gemcitabine</arm_group_label>
    <other_name>Gemcitabine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Signed informed consent form obtained prior to treatment. The patients were fully&#xD;
             explained and understood the purpose, contents, predicted efficacy, pharmacological&#xD;
             effects, and risks of this study.&#xD;
&#xD;
             2. target patients&#xD;
&#xD;
               1. the patients were histopathologically- or cytocologically-confirmed as metastatic&#xD;
                  pancreatic cancer.&#xD;
&#xD;
               2. At least one measurable objective lesion (both primary and metastatic) was&#xD;
                  identified based on the RECIST 1.1 criteria;&#xD;
&#xD;
               3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
               4. The expected survival after surgery ≥ 3 months&#xD;
&#xD;
               5. The subjects have good compliance, can be treated and followed up, and&#xD;
                  voluntarily comply with the relevant provisions of this study&#xD;
&#xD;
               6. No contraindications for camrelizumab, gemcitabine and nab-paclitaxel. 3. Age and&#xD;
                  reproductive status&#xD;
&#xD;
               1. Male and female patients at the age of 18-75&#xD;
&#xD;
               2. Subjects of child-bearing age must agree to take effective contraceptive measures&#xD;
                  during the study period; Serum or urine pregnancy tests must be negative for&#xD;
                  women of childbearing age 24 hours before the start of therapy;&#xD;
&#xD;
               3. Women must not lactate.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  1. The target disease has cerebral metastasis; 2. Previously treated by anti-PD-1 or&#xD;
             anti-PD-L1 drugs; 3. Received any investigational drug within 4 weeks before the first&#xD;
             use of the research drug; 4. Enrolled in another clinical study, unless it is an&#xD;
             observational (non-interventional) clinical study or an interventional follow-up&#xD;
             clinical study; 5. medical history and complications&#xD;
&#xD;
               1. patients had uncontrolled serious medical condition that the investigator&#xD;
                  considered may affect the subject's to receive treatment under the study program.&#xD;
                  For example, patients with severe medical diseases, including severe heart&#xD;
                  disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled&#xD;
                  hypertension, uncontrolled infection, active peptic ulcer, etc.&#xD;
&#xD;
               2. patients who are suffering active, known or suspected autoimmune diseases&#xD;
                  (including but limited to uveitis, enteritis, hepatitis, pituitary inflammation,&#xD;
                  nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring&#xD;
                  bronchodilator therapy, etc.). Subjects with hypothyroidism who only need hormone&#xD;
                  replacement therapy and skin diseases that do not require systemic treatment&#xD;
                  (such as vitiligo, psoriasis, or hair loss) can be enrolled;&#xD;
&#xD;
               3. Patients who are suffering from active tuberculosis infection: Patients with&#xD;
                  active pulmonary tuberculosis infection within 1 year before medication should be&#xD;
                  excluded even if they have been treated; patients with a history of active&#xD;
                  tuberculosis infection more than 1 year ago should also be excluded unless it is&#xD;
                  proven that they have received standard anti-TB treatment before;&#xD;
&#xD;
               4. Patients who have previous interstitial lung disease or (non-infectious)&#xD;
                  pneumonia and requires oral or intravenous steroid therapy;&#xD;
&#xD;
               5. Patients who need to receive long-term systemic hormones (dose equivalent to&#xD;
                  &gt;10mg prednisone/day) or any other form of immunosuppressive therapy. Subjects&#xD;
                  using inhaled or topical corticosteroids can be enrolled;&#xD;
&#xD;
               6. Patients who have uncontrolled heart disease, such as:&#xD;
&#xD;
                    1. New York Heart Association (NYHA) level 2 heart failure;&#xD;
&#xD;
                    2. Unstable angina;&#xD;
&#xD;
                    3. Myocardial infarction occurred within 1 year&#xD;
&#xD;
                    4. Supraventricular or ventricular arrhythmias that have clinical significance&#xD;
                       and require treatment or intervention&#xD;
&#xD;
               7. Dementia, changing of mental state or any mental illness which could hinder&#xD;
                  understanding or informed consent or fill out questionnaires;&#xD;
&#xD;
               8. History of allergy or hypersensitivity to any therapeutic ingredient;&#xD;
&#xD;
               9. Combined with other malignant tumors excepted pancreatic cancer within the first&#xD;
                  5 years of randomization, excepted well-treated basal cell or squamous cell&#xD;
                  carcinoma of the skin, localized prostate cancer after radical resection, and&#xD;
                  ductal carcinoma in situ of the breast after radical resection;&#xD;
&#xD;
              10. Previously received systemic therapy for advanced/metastatic pancreatic cancer;&#xD;
&#xD;
              11. Subjects who had previously been pathologically diagnosed with squamous cell&#xD;
                  carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with&#xD;
                  taxa regimen.&#xD;
&#xD;
              12. Patients who had Grade 2 or above Peripheral neuropathy according to CTCAE Ver.&#xD;
                  5.0.&#xD;
&#xD;
             6. Abnormal results of physical examination and laboratory examination&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelets (PLT) ≥ 80×109/L;&#xD;
                  Hemoglobin (Hb) ≥ 90g/L&#xD;
&#xD;
               2. Aspartate aminotransferase (AST, or serum glutamic oxaloacetic transaminase,&#xD;
                  SGOT) and alanine aminotransferase (ALT, or serum glutamic pyruvate transaminase,&#xD;
                  SGPT) &gt; 2.5 × ULN (institutional upper limit of normal), &gt; 5 ×ULN (hepatic&#xD;
                  metastases occasion); Total bilirubin (TBIL)&gt;1.5 × ULN;&#xD;
&#xD;
               3. Creatinine (CRE)&gt; 1.5 × ULN&#xD;
&#xD;
               4. Prothrombin time (PT) and international normalized ratio (INR) &gt; 1.5 × ULN. Or&#xD;
                  activated partial thromboplastin time (aPTT) &gt; 1.5 × ULN. Unless the subject had&#xD;
                  received anticoagulant treatment&#xD;
&#xD;
               5. Subjects had hepatitis b surface antigen (HBsAg)-positive and HBV-DNA titer in&#xD;
                  peripheral blood greater than or equal to 1000 copy number /L; If HBsAg is&#xD;
                  positive and the HBV-DNA of peripheral blood ≥ 1000 copy number/L, the subjects&#xD;
                  will be eligible for inclusion if the investigator considers that chronic&#xD;
                  hepatitis b is stable and does not increase the risk of subjects.&#xD;
&#xD;
             4. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients;&#xD;
             5. Patients who suffer from active infection requiring systemic treatment; 6. Patients&#xD;
             need other concomitant anti-tumor drugs; 7. Participation in any trial drug treatment&#xD;
             or another interventional clinical trial 30 days before screening period.&#xD;
&#xD;
             8. Other conditions that the investigators considered are not suitable for the&#xD;
             enrollment.&#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>Xian-Jun Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xian-Jun Yu</last_name>
    <phone>+86 21 64175590</phone>
    <email>wangwenquan@fudanpci.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wen-Quan Wang</last_name>
    <email>wangwenquan@fudanpci.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xian-Jun Yu, M.D., Ph.D.</last_name>
      <phone>+86-21-6417-5590</phone>
      <email>yuxianjun@fudanpci.org</email>
    </contact>
    <contact_backup>
      <last_name>Wen-Quan Wang, M.D., Ph.D.</last_name>
      <phone>+86-21-6417-5590</phone>
      <email>wangwenquan@fudanpci.org</email>
    </contact_backup>
    <investigator>
      <last_name>Xianjun Yu, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xian-Jun Yu</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </responsible_party>
  <keyword>Metastatic pancreatic cancer</keyword>
  <keyword>Pancreatic Adenocarcinoma</keyword>
  <keyword>Camrelizumab</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <keyword>Gemcitabine</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>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04498689
org study id: CSPAC-27
nct id: NCT04498689
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The present study is intended to investigate the objective response rate (ORR) and the
      progression-free survival (PFS) of the patients with histologically- or
      cytologically-confirmed metastatic pancreatic cancer after treating with the combination of
      camrelizumab, gemcitabine and nab-paclitaxel, and to investigate the overall survival (OS)
      and the adverse event (AE) of the patients with histologically- or cytologically-confirmed
      metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine
      and nab-paclitaxel.
This a prospective, single-arm, open-label, phase 2 studye evaluating the efficacy and safety
      of camrelizumab, gemcitabine and nab-paclitaxel for metastatic pancreatic cancer patients.
      The primary endpoints are ORR and PFS, and the secondary are OS and adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
description: To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
measure: Progression Free Survival
time frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
description: To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
measure: overall survival
time frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
description: To evaluate the overall survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
measure: adverse events
time frame: from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months
description: To evaluate the adverse events of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.
arm group label: camrelizumab + nab-paclitaxel + gemcitabine
arm group type: Experimental
description: PD-1 Monoclonal Antibody Camrelizumab at 200 mg on Day 1 and 15 nab-paclitaxel at 100 mg/m2 on Day 1, 8, and 15; gemcitabine at 1000 mg/m2 on Day 1, 8, and 15
intervention type: Drug
intervention name: Camrelizumab
description: Patients firstly receive camrelizumab 200 mg per time (iv, no less than 20 minutes and no more than 60 minutes, rinse time included) on Day 1 and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
arm group label: camrelizumab + nab-paclitaxel + gemcitabine
intervention type: Drug
intervention name: Nab paclitaxel
description: Patients secondly receive nab-paclitaxel 100 mg/m2 (iv, at least 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
arm group label: camrelizumab + nab-paclitaxel + gemcitabine
other name: Albumin paclitaxl
intervention type: Drug
intervention name: Gemcitabine Injection
description: At last, patients receive gemcitabine 1000 mg/m2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
arm group label: camrelizumab + nab-paclitaxel + gemcitabine
other name: Gemcitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xian-Jun Yu
role: Principal Investigator
affiliation: Fudan University
last name: Xian-Jun Yu
phone: +86 21 64175590
email: wangwenquan@fudanpci.org
last name: Wen-Quan Wang
email: wangwenquan@fudanpci.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xian-Jun Yu
investigator title: Vice President
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
sharing ipd: No