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/NCT05976568</url>
    </required_header>
    <id_info>
      <org_study_id>QL1706-308</org_study_id>
      <nct_id>NCT05976568</nct_id>
    </id_info>
    <brief_title>A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma</brief_title>
    <official_title>A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this study is to assess the efficacy and safety of QL1706 in combination with&#xD;
        bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as&#xD;
        first-line treatment in patients with advanced hepatocellular carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2027</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective Response Rate (ORR) (Phase II)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Adverse Events (AEs) (Phase II)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall Survival (OS) (Phase III)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>OS was defined as the time from randomization to death due to any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>ORR was assessed by investigators per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>DCR was assessed by investigators per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>DOR was assessed by investigators per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free Survival (PFS)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>PFS was assessed by investigators per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to progression (TTP)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>TTP was assessed by investigators per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>ORR was assessed by investigators per mRECIST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>DCR was assessed by investigators per mRECIST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>DOR was assessed by investigators per mRECIST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free Survival (PFS)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>PFS was assessed by investigators per mRECIST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to progression (TTP)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>TTP was assessed by investigators per mRECIST</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">668</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>QL1706 in combination with bevacizumab and chemotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>QL1706 in combination with bevacizumab</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>QL1706 in combination with chemotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 4</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sintilimab in combination with bevacizumab</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>QL1706</intervention_name>
      <description>7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
      <arm_group_label>Arm 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab</intervention_name>
      <description>15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
      <arm_group_label>Arm 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxaliplatin injection</intervention_name>
      <description>85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sintilimab</intervention_name>
      <description>200 mg administered as IV infusion on Day 1 of each 21-day cycle</description>
      <arm_group_label>Arm 4</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects participate voluntarily and sign informed consent.&#xD;
  &#xD;
            2. Age ≥ 18 and ≤ 80 years old, male or female.&#xD;
  &#xD;
            3. Histological or cytological or clinical diagnosis of HCC&#xD;
  &#xD;
            4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery&#xD;
               and/or local treatment.&#xD;
  &#xD;
            5. No prior systemic therapy for HCC.&#xD;
  &#xD;
            6. Child-Pugh ≤7 , no history of hepatic encephalopathy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Histologically or cytologically documented fibrolamellar hepatocellular carcinoma,&#xD;
               sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.&#xD;
  &#xD;
            2. History of malignancy other than HCC within 5 years prior to the start of study&#xD;
               treatment.&#xD;
  &#xD;
            3. History of liver transplantation, or planned to receive liver transplantation.&#xD;
  &#xD;
            4. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled&#xD;
               or moderate or severe pleural and pericardical effusion.&#xD;
  &#xD;
            5. Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
               meningitis.&#xD;
  &#xD;
            6. Involvement of both the main portal vein and the left and right branches by portal&#xD;
               vein tumor thrombus, or of both the main trunk and the superior mesenteric vein&#xD;
               concurrently, or of inferior vena cava.&#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>Jia Fan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Shukui Qin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nanjing Tianyinshan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian Gao</last_name>
      <phone>+8613304321400</phone>
      <email>jian7.gao@qilu-pharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nanjing Tianyinshan Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>211199</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Shukui Qin</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhongshan Hospital, Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jia Fan</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Capecitabine</mesh_term>
      <mesh_term>Oxaliplatin</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/NCT05976568
  org study id: QL1706-308
  nct id: NCT05976568
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the efficacy and safety of QL1706 in combination with
        bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as
        first-line treatment in patients with advanced hepatocellular carcinoma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR) (Phase II)
  time frame: Up to approximately 4 years
  description: ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  measure: Incidence of Adverse Events (AEs) (Phase II)
  time frame: Up to approximately 4 years
  description: An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
  measure: Overall Survival (OS) (Phase III)
  time frame: Up to approximately 4 years
  description: OS was defined as the time from randomization to death due to any cause.
  measure: Objective Response Rate (ORR)
  time frame: Up to approximately 4 years
  description: ORR was assessed by investigators per RECIST 1.1
  measure: Disease Control Rate (DCR)
  time frame: Up to approximately 4 years
  description: DCR was assessed by investigators per RECIST 1.1
  measure: Duration of Response (DOR)
  time frame: Up to approximately 4 years
  description: DOR was assessed by investigators per RECIST 1.1
  measure: Progression-free Survival (PFS)
  time frame: Up to approximately 4 years
  description: PFS was assessed by investigators per RECIST 1.1
  measure: Time to progression (TTP)
  time frame: Up to approximately 4 years
  description: TTP was assessed by investigators per RECIST 1.1
  measure: Objective Response Rate (ORR)
  time frame: Up to approximately 4 years
  description: ORR was assessed by investigators per mRECIST
  measure: Disease Control Rate (DCR)
  time frame: Up to approximately 4 years
  description: DCR was assessed by investigators per mRECIST
  measure: Duration of Response (DOR)
  time frame: Up to approximately 4 years
  description: DOR was assessed by investigators per mRECIST
  measure: Progression-free Survival (PFS)
  time frame: Up to approximately 4 years
  description: PFS was assessed by investigators per mRECIST
  measure: Time to progression (TTP)
  time frame: Up to approximately 4 years
  description: TTP was assessed by investigators per mRECIST
  arm group label: Arm 1
  arm group type: Experimental
  description: QL1706 in combination with bevacizumab and chemotherapy
  arm group label: Arm 2
  arm group type: Experimental
  description: QL1706 in combination with bevacizumab
  arm group label: Arm 3
  arm group type: Experimental
  description: QL1706 in combination with chemotherapy
  arm group label: Arm 4
  arm group type: Active Comparator
  description: Sintilimab in combination with bevacizumab
  intervention type: Drug
  intervention name: QL1706
  description: 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
  arm group label: Arm 1
  arm group label: Arm 2
  arm group label: Arm 3
  intervention type: Drug
  intervention name: Bevacizumab
  description: 15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
  arm group label: Arm 1
  arm group label: Arm 2
  arm group label: Arm 4
  intervention type: Drug
  intervention name: Oxaliplatin injection
  description: 85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
  arm group label: Arm 1
  arm group label: Arm 3
  intervention type: Drug
  intervention name: Capecitabine
  description: 1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
  arm group label: Arm 1
  arm group label: Arm 3
  intervention type: Drug
  intervention name: Sintilimab
  description: 200 mg administered as IV infusion on Day 1 of each 21-day cycle
  arm group label: Arm 4
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jia Fan
  role: Principal Investigator
  affiliation: Fudan University
  last name: Shukui Qin
  role: Principal Investigator
  affiliation: Nanjing Tianyinshan Hospital
  last name: Jian Gao
  phone: +8613304321400
  email: jian7.gao@qilu-pharma.com
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Bevacizumab
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  sharing ipd: No