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/NCT05963087</url>
    </required_header>
    <id_info>
      <org_study_id>Braf-001</org_study_id>
      <nct_id>NCT05963087</nct_id>
    </id_info>
    <brief_title>Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer</brief_title>
    <official_title>Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer: a Prospective, Exploratory, Phase II Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang Cancer Hospital</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>
        To explore the efficacy and safety of Cetuximab in combination with dabrafenib and&#xD;
        Tislelizumab in BRAF mutated treatment of advanced colorectal cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Due to Encorafenib has not been marketed in China, it is difficult to benefit patients, and&#xD;
        there are no reported studies of Dabrafenib, also a BRAF inhibitor, in combination with&#xD;
        anti-EGFR monoclonal antibody and immunotherapy in BRAF mutated mCRC. Therefore, we intend to&#xD;
        use Dabrafenib in combination with cetuximab and Tislelizumab in the treatment of BRAF V600E&#xD;
        mutated patients with advanced colorectal cancer to observe the initial efficacy and safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">February 2025</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>Objective response rate (ORR)</measure>
      <time_frame>up to 12 months</time_frame>
      <description>CR + PR rate according to the RECIST version 1.1 guidelines.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS）</measure>
      <time_frame>up to 12 months</time_frame>
      <description>To assess the efficacy of Surufatinib Combine With Immunotherapy and Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival time</measure>
      <time_frame>up to 36 months</time_frame>
      <description>OS was calculated from the date of pharmacy to death from any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Advanced Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Advanced CRC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with BRAF Mutated Advanced CRC were given Cetuximab in Combination With Dabrafenib and Tislelizumab</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cetuximab Dabrafenib Tislelizumab</intervention_name>
      <description>Dabrafenib 150mg，BID, Cetuximab 250mg/m2, Tislelizumab 200mg Treatment every three weeks</description>
      <arm_group_label>Advanced CRC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Histopathological diagnosis of advanced colorectal cancer; 2. Previous first-line&#xD;
               standard treatment failed or could not tolerate first-line standard treatment; 3. BRAF&#xD;
               V600E mutation (NGS or ARMS-PCR assay); 4.18 years old≤ Age≤75 years old; 5. PS score&#xD;
               0-1; 6. At least one measurable or evaluable lesion according to RECIST v1.1; 7.&#xD;
               Baseline color Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥60%; 8.&#xD;
               Has adequate organ and bone marrow function; 9. Expected survival ≥12 weeks 10. Female&#xD;
               subjects of childbearing age or male subjects whose sexual partner is a female of&#xD;
               childbearing age are required to take effective contraceptive measures throughout the&#xD;
               treatment period and for 6 months after the treatment period 11. Sign a written&#xD;
               informed consent and be able to comply with the visit and related procedures required&#xD;
               by the program;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Malignant diseases other than colorectal cancer diagnosed within 5 years prior to&#xD;
               first administration (excluding radical treatment)Carcinomas in situ with sexual&#xD;
               resection); 2. Currently participating in the intervention clinical study treatment,&#xD;
               or receiving other study drugs or using study devices within 4 weeks before the first&#xD;
               dose; 3. Previous treatment with BRAF inhibitors, MEK inhibitors, anti-PD-1,&#xD;
               anti-PD-L1, or anti-PD-L2 drugs, or drugs that target another stimulus or synergically&#xD;
               inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic systemic&#xD;
               treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory&#xD;
               drugs (including thymosin, interferon, interleukin, except for local use to control&#xD;
               pleural fluid) within 2 weeks before the first administration; 5. An active autoimmune&#xD;
               disease requiring systemic treatment (e.g. with disease-modifying drugs,&#xD;
               glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial&#xD;
               administration. Replacement therapies (such as thyroxine, insulin, or physiologic&#xD;
               glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic&#xD;
               therapy; 6. Were receiving systemic glucocorticoid therapy (excluding topical&#xD;
               glucocorticoids by nasal spray, inhalation, or other route) or any other form of&#xD;
               immunosuppressive therapy within 7 days prior to initial administration of the study&#xD;
               7. Known allogeneic organ transplantation (except corneal transplantation) or&#xD;
               allogeneic hematopoietic stem cell transplantation 8. Known allergy to any monoclonal&#xD;
               antibody formulation ingredient (grade 3 or above allergic reaction) 9. Has not fully&#xD;
               recovered from toxicity and/or complications caused by any intervention before&#xD;
               starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss); 10.&#xD;
               Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody&#xD;
               positive); 11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA&#xD;
               copy number detected greater than the upper limit of normal value in the laboratory of&#xD;
               the study center); 12. Active HCV-infected subjects (HCV antibody positive and HCV-RNA&#xD;
               levels above the lower limit of detection); 13. Received live vaccine within 30 days&#xD;
               prior to the first dose (cycle 1, day 1); 14. Pregnant or lactating women; 15. The&#xD;
               presence of any serious or uncontrolled systemic disease 16. Medical history or&#xD;
               evidence of disease that may interfere with test results, prevent participants from&#xD;
               fully participating in the study, abnormal treatment or laboratory test values, or&#xD;
               other conditions that the investigator considers unsuitable for enrollment The&#xD;
               Investigator considers other potential risks unsuitable for participation in the&#xD;
               study.&#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>Wangxia Lv</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhejiang Cancer Institute &amp; Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wangxia Lv</last_name>
      <phone>13757141026</phone>
      <email>lvwangxia@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhejiang Cancer Institute &amp; Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wangxia Lv</last_name>
        <phone>13757141026</phone>
        <email>lvwangxia@163.com</email>
      </contact>
      <investigator>
        <last_name>Hanjun Zhong</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Meiqin Yuan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Bixia Liu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zhong Shi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yazhen Zhao</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Junchi Cheng</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang Cancer Hospital</investigator_affiliation>
      <investigator_full_name>Wangxia LV</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cetuximab</mesh_term>
      <mesh_term>Tislelizumab</mesh_term>
      <mesh_term>Dabrafenib</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/NCT05963087
  org study id: Braf-001
  nct id: NCT05963087
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To explore the efficacy and safety of Cetuximab in combination with dabrafenib and
        Tislelizumab in BRAF mutated treatment of advanced colorectal cancer
  Due to Encorafenib has not been marketed in China, it is difficult to benefit patients, and
        there are no reported studies of Dabrafenib, also a BRAF inhibitor, in combination with
        anti-EGFR monoclonal antibody and immunotherapy in BRAF mutated mCRC. Therefore, we intend to
        use Dabrafenib in combination with cetuximab and Tislelizumab in the treatment of BRAF V600E
        mutated patients with advanced colorectal cancer to observe the initial efficacy and safety.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: up to 12 months
  description: CR + PR rate according to the RECIST version 1.1 guidelines.
  measure: Progression Free Survival (PFS）
  time frame: up to 12 months
  description: To assess the efficacy of Surufatinib Combine With Immunotherapy and Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  measure: Overall survival time
  time frame: up to 36 months
  description: OS was calculated from the date of pharmacy to death from any cause.
  arm group label: Advanced CRC
  arm group type: Experimental
  description: Patients with BRAF Mutated Advanced CRC were given Cetuximab in Combination With Dabrafenib and Tislelizumab
  intervention type: Drug
  intervention name: Cetuximab Dabrafenib Tislelizumab
  description: Dabrafenib 150mg，BID, Cetuximab 250mg/m2, Tislelizumab 200mg Treatment every three weeks
  arm group label: Advanced CRC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Wangxia Lv
  role: Principal Investigator
  affiliation: Zhejiang Cancer Institute & Hospital
  last name: Wangxia Lv
  phone: 13757141026
  email: lvwangxia@163.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang Cancer Hospital
  investigator full name: Wangxia LV
  investigator title: MD
  mesh term: Colorectal Neoplasms
  mesh term: Cetuximab
  mesh term: Tislelizumab
  mesh term: Dabrafenib