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/NCT05978609</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1036</org_study_id>
      <nct_id>NCT05978609</nct_id>
    </id_info>
    <brief_title>Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer</brief_title>
    <official_title>Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West China 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>
        The goal of this single-arm, Phase II interventional clinical trial is to test the safety and&#xD;
        effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin&#xD;
        in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  Is this combined treatment protocol safe for these patients?&#xD;
  &#xD;
          -  Is this combined treatment protocol effective in treating these patients?&#xD;
  &#xD;
        Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and&#xD;
        Cisplatin. Researchers will monitor their health conditions to assess the safety and&#xD;
        effectiveness of this treatment protocol.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>through study completion, an average of 1 year</time_frame>
      <description>Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>overall survival (OS)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>To evaluate the overall survival (OS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.</description>
    </other_outcome>
    <other_outcome>
      <measure>progression free survival (PFS)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>To evaluate the progression free survival (PFS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Cholangiocarcinoma Non-resectable</condition>
    <arm_group>
      <arm_group_label>Candonilimab in combination with cisplatin and gemcitabine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors&#xD;
  Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；&#xD;
  Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；&#xD;
  gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Candonilimab</intervention_name>
      <description>Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；</description>
      <arm_group_label>Candonilimab in combination with cisplatin and gemcitabine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；</description>
      <arm_group_label>Candonilimab in combination with cisplatin and gemcitabine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；</description>
      <arm_group_label>Candonilimab in combination with cisplatin and gemcitabine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Obtain written informed consent before implementing any experimental procedures.&#xD;
  &#xD;
            2. Age between 18 and 75 years (any gender).&#xD;
  &#xD;
            3. Histologically or cytologically confirmed unresectable locally advanced or metastatic&#xD;
               biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and&#xD;
               gallbladder carcinoma).&#xD;
  &#xD;
            4. No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the&#xD;
               past 6 months.&#xD;
  &#xD;
            5. Expected survival time &gt; 3 months.&#xD;
  &#xD;
            6. Presence of at least one measurable lesion according to RECIST 1.1 criteria.&#xD;
  &#xD;
            7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.&#xD;
  &#xD;
            8. Adequate organ function, with the following laboratory criteria:&#xD;
  &#xD;
                 1. Absolute neutrophil count (ANC) ≥ 1.5x10^9/L, without the use of&#xD;
                    granulocyte-colony stimulating factor in the past 14 days.&#xD;
  &#xD;
                 2. Platelet count ≥ 90x10^9/L, without transfusion in the past 14 days.&#xD;
  &#xD;
                 3. Hemoglobin &gt; 9 g/dL, without transfusion or use of erythropoietin-stimulating&#xD;
                    agents in the past 14 days.&#xD;
  &#xD;
                 4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).&#xD;
  &#xD;
                 5. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (ALT&#xD;
                    or AST ≤ 5 times ULN for patients with liver metastases).&#xD;
  &#xD;
                 6. Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the&#xD;
                    Cockcroft-Gault formula) ≥ 60 ml/min.&#xD;
  &#xD;
                 7. Coagulation function within normal limits, defined as international normalized&#xD;
                    ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.&#xD;
  &#xD;
                 8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the&#xD;
                    normal range. If baseline TSH is outside the normal range, subjects with total&#xD;
                    triiodothyronine (T3) (or free T3) and free thyroxine (FT4) within the normal&#xD;
                    range can still be included.&#xD;
  &#xD;
                 9. Normal cardiac enzymes (clinically insignificant isolated laboratory&#xD;
                    abnormalities are allowed, as determined by the investigator).&#xD;
  &#xD;
            9. For premenopausal female subjects, a negative pregnancy test result (urine or serum)&#xD;
               should be obtained within 3 days before the first dose of study drug (Day 1 of Cycle&#xD;
               1). If urine pregnancy test results cannot be confirmed as negative, a blood pregnancy&#xD;
               test is required. Postmenopausal female is defined as at least 1 year after menopause&#xD;
               or having undergone surgical sterilization or hysterectomy.&#xD;
  &#xD;
           10. If there is a risk of pregnancy, all subjects (both male and female) must use&#xD;
               contraception with a failure rate of less than 1% per year throughout the entire&#xD;
               treatment period and for 120 days after the last dose of study drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding&#xD;
               completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or&#xD;
               in situ carcinoma within the past 5 years.&#xD;
  &#xD;
            2. Tumors located in the ampulla of Vater.&#xD;
  &#xD;
            3. Currently participating in an interventional clinical study or received other&#xD;
               investigational drugs or investigational device treatment within 4 weeks prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
            4. Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs&#xD;
               targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g.,&#xD;
               CTLA-4, OX-40, CD137).&#xD;
  &#xD;
            5. Previously received palliative radiotherapy for biliary tumors, excluding&#xD;
               postoperative adjuvant radiotherapy.&#xD;
  &#xD;
            6. Received traditional Chinese medicine or immune modulatory drugs with anti-tumor&#xD;
               indications within 2 weeks prior to the first dose of study drug (including thymosin,&#xD;
               interferon, interleukins), except for local use to control pleural effusion.&#xD;
  &#xD;
            7. Active autoimmune diseases requiring systemic treatment within 2 years prior to the&#xD;
               first dose of study drug, or known history of primary immunodeficiency diseases.&#xD;
               Patients with positive autoimmune antibodies alone will be evaluated by the&#xD;
               investigator to determine if they have autoimmune diseases.&#xD;
  &#xD;
            8. Currently receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or&#xD;
               topical corticosteroids) or any other form of immunosuppressive therapy within 4 weeks&#xD;
               prior to the first dose of study drug. Physiological doses of corticosteroids (≤10&#xD;
               mg/day prednisone or equivalent) are permitted.&#xD;
  &#xD;
            9. Uncontrolled pleural effusion or ascites that requires drainage or has not shown a&#xD;
               significant increase in the past 3 days in patients who do not require drainage or&#xD;
               whose drainage has been stopped.&#xD;
  &#xD;
           10. Prior solid organ transplantation (excluding corneal transplantation) or allogeneic&#xD;
               hematopoietic stem cell transplantation.&#xD;
  &#xD;
           11. Known hypersensitivity to the study drug, Candonilimab active substance, or&#xD;
               excipients.&#xD;
  &#xD;
           12. Insufficient recovery from any toxicities and/or complications related to previous&#xD;
               interventions before starting treatment (i.e., ≤ Grade 1 or returning to baseline,&#xD;
               excluding fatigue or alopecia).&#xD;
  &#xD;
           13. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV&#xD;
               1/2 antibodies).&#xD;
  &#xD;
           14. Untreated active hepatitis B defined as positive HBsAg and detectable HBV-DNA levels&#xD;
               above the upper limit of normal at the study center. Note: The following HBV-infected&#xD;
               patients may be included:&#xD;
  &#xD;
               HBV viral load &lt;2.5 × 10^3 copies/mL (500 IU/mL) prior to the first dose of study&#xD;
               drug, and patients should receive anti-HBV therapy throughout the study treatment.&#xD;
  &#xD;
               For patients who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV DNA&#xD;
               negative, no prophylactic anti-HBV therapy is required, but viral reactivation needs&#xD;
               to be closely monitored.&#xD;
  &#xD;
           15. Active hepatitis C infection (positive for hepatitis C virus (HCV) antibodies and&#xD;
               HCV-RNA levels above the lower limit of detection).&#xD;
  &#xD;
           16. Vaccination with live attenuated vaccines within 4 weeks prior to the first dose of&#xD;
               study drug.&#xD;
  &#xD;
           17. Pregnant or lactating women.&#xD;
  &#xD;
           18. Presence of any severe or uncontrolled systemic diseases, including:&#xD;
  &#xD;
               Resting electrocardiogram with significant and symptomatic abnormalities in rhythm,&#xD;
               conduction, or morphology, such as complete left bundle branch block, grade II or&#xD;
               higher cardiac conduction block, ventricular arrhythmia, or atrial fibrillation.&#xD;
  &#xD;
               Unstable angina, congestive heart failure, chronic heart failure with New York Heart&#xD;
               Association (NYHA) classification ≥ Grade 2.&#xD;
  &#xD;
               Any arterial thrombosis, embolism, or ischemia event within the past 6 months prior to&#xD;
               enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident,&#xD;
               or transient ischemic attack.&#xD;
  &#xD;
               Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to&#xD;
               the first dose of study drug or unhealed wounds, ulcers, or fractures. Minor surgical&#xD;
               procedures, including venous puncture for intravenous infusion, within 7 days prior to&#xD;
               the first dose of study drug are excluded.&#xD;
  &#xD;
               Poor blood pressure control (systolic blood pressure &gt;140 mmHg, diastolic blood&#xD;
               pressure &gt;90 mmHg).&#xD;
  &#xD;
               Active pulmonary tuberculosis. Active or uncontrolled infections requiring systemic&#xD;
               treatment. Clinical active diverticulitis, intra-abdominal abscess, or&#xD;
               gastrointestinal obstruction.&#xD;
  &#xD;
               Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active&#xD;
               hepatitis.&#xD;
  &#xD;
               Poorly controlled diabetes (fasting blood glucose &gt;10 mmol/L). Urine analysis showing&#xD;
               urinary protein ≥++ and confirmed 24-hour urinary protein &gt;1.0 g.&#xD;
  &#xD;
               Presence of psychiatric disorders that would hinder compliance with treatment.&#xD;
  &#xD;
           19. Any medical history, evidence of disease, or abnormal laboratory values that could&#xD;
               interfere with the study results, hinder the subject's full participation in the&#xD;
               study, or pose other potential risks as determined by the investigator.&#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_contact>
      <last_name>Tao Wang</last_name>
      <phone>17844623533</phone>
      <email>wangshoutao1219@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>West China Hospital, Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tao Wang, Dr.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>West China Hospital</investigator_affiliation>
      <investigator_full_name>Wentao Wang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholangiocarcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05978609
  org study id: 2023-1036
  nct id: NCT05978609
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this single-arm, Phase II interventional clinical trial is to test the safety and
        effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin
        in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The
        main questions it aims to answer are:
  
          -  Is this combined treatment protocol safe for these patients?
  
          -  Is this combined treatment protocol effective in treating these patients?
  
        Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and
        Cisplatin. Researchers will monitor their health conditions to assess the safety and
        effectiveness of this treatment protocol.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate(ORR)
  time frame: through study completion, an average of 1 year
  description: Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  time frame: through study completion, an average of 1 year
  measure: overall survival (OS)
  time frame: through study completion, an average of 1 year
  description: To evaluate the overall survival (OS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.
  measure: progression free survival (PFS)
  time frame: through study completion, an average of 1 year
  description: To evaluate the progression free survival (PFS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.
  arm group label: Candonilimab in combination with cisplatin and gemcitabine
  arm group type: Experimental
  description: This study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors
  Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  intervention type: Drug
  intervention name: Candonilimab
  description: Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  arm group label: Candonilimab in combination with cisplatin and gemcitabine
  intervention type: Drug
  intervention name: Cisplatin
  description: Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  arm group label: Candonilimab in combination with cisplatin and gemcitabine
  intervention type: Drug
  intervention name: Gemcitabine
  description: gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
  arm group label: Candonilimab in combination with cisplatin and gemcitabine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Tao Wang
  phone: 17844623533
  email: wangshoutao1219@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: West China Hospital
  investigator full name: Wentao Wang
  investigator title: Professor
  mesh term: Cholangiocarcinoma
  mesh term: Gemcitabine
  sharing ipd: Undecided