<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/NCT04401800</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-A317-211</org_study_id>
    <secondary_id>CTR20200972</secondary_id>
    <nct_id>NCT04401800</nct_id>
  </id_info>
  <brief_title>Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma</brief_title>
  <official_title>A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeiGene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeiGene</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 primary objective of this study is to assess the preliminary antitumor activity as&#xD;
      indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in&#xD;
      participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR) as assessed by Central Imaging Facility based on RECIST v1.1</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Adverse Events (AEs)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Severe Adverse Events (SAEs)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration Of Response (DOR)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Unresectable Hepatocellular Carcinoma</condition>
  <condition>Metastatic Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Part 1: Safety Run-in</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenvatinib at the recommended phase 2 dose (RP2D) determined from Part 1 + tislelizumab in 21-day cycles for up to 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>Capsules administered orally once daily</description>
    <arm_group_label>Part 1: Safety Run-in</arm_group_label>
    <arm_group_label>Part 2: Lenvatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tislelizumab</intervention_name>
    <description>200 mg intravenous (IV) infusion administered on Day 1 of each cycle</description>
    <arm_group_label>Part 1: Safety Run-in</arm_group_label>
    <arm_group_label>Part 2: Lenvatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Unresectable locally advanced or metastatic HCC, which must be confirmed by&#xD;
             histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed&#xD;
             cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.&#xD;
&#xD;
          2. Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is&#xD;
             not amenable to or has progressed after loco-regional therapy and is not amenable to a&#xD;
             curative treatment approach&#xD;
&#xD;
          3. Did not receive any systemic treatment before and is unwilling to accept standard of&#xD;
             care treatment or not suitable for standard of care treatment as judged by&#xD;
             investigators&#xD;
&#xD;
          4. European Cancer Oncology Group (ECOG) Performance Status ≤ 1&#xD;
&#xD;
          5. Child-Pugh A classification for liver function assessed within 7 days of first dose of&#xD;
             study drugs&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Active autoimmune diseases or history of autoimmune diseases that may relapse&#xD;
&#xD;
          2. Any active malignancy ≤ 2 years before the first dose of study drugs except for&#xD;
             specific cancer under investigation in this study and any locally recurring cancer&#xD;
             that has been treated curatively (eg, resected basal or squamous cell skin cancer,&#xD;
             superficial bladder cancer, carcinoma in situ of the cervix or breast)&#xD;
&#xD;
          3. Uncontrolled diabetes or &gt; Grade 1 laboratory test abnormalities in potassium, sodium,&#xD;
             or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia&#xD;
             ≤ 14 days before the first dose of study drugs&#xD;
&#xD;
          4. Any known brain or leptomeningeal metastases&#xD;
&#xD;
          5. Concurrent participation in another therapeutic clinical study&#xD;
&#xD;
        NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol&#xD;
        defined Inclusion/Exclusion criteria may apply.&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi 'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital ,Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University - Cancer Center (SYSUCC)</name>
      <address>
        <city>Guangzhou</city>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 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>Lenvatinib</mesh_term>
    <mesh_term>Tislelizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04401800
org study id: BGB-A317-211
secondary id: CTR20200972
nct id: NCT04401800
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to assess the preliminary antitumor activity as
      indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in
      participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR) as assessed by Central Imaging Facility based on RECIST v1.1
time frame: Up to 12 months
measure: Number of participants experiencing Adverse Events (AEs)
time frame: Up to 12 months
measure: Number of participants experiencing Severe Adverse Events (SAEs)
time frame: Up to 12 months
measure: Overall Response Rate (ORR)
time frame: Up to 12 months
measure: Duration Of Response (DOR)
time frame: Up to 12 months
measure: Disease Control Rate (DCR)
time frame: Up to 12 months
measure: Progression-Free Survival (PFS)
time frame: Up to 12 months
arm group label: Part 1: Safety Run-in
arm group type: Experimental
description: Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle
arm group label: Part 2: Lenvatinib
arm group type: Experimental
description: Lenvatinib at the recommended phase 2 dose (RP2D) determined from Part 1 + tislelizumab in 21-day cycles for up to 12 months
intervention type: Drug
intervention name: Lenvatinib
description: Capsules administered orally once daily
arm group label: Part 1: Safety Run-in
arm group label: Part 2: Lenvatinib
intervention type: Drug
intervention name: Tislelizumab
description: 200 mg intravenous (IV) infusion administered on Day 1 of each cycle
arm group label: Part 1: Safety Run-in
arm group label: Part 2: Lenvatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: BeiGene
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Lenvatinib
mesh term: Tislelizumab
sharing ipd: Yes