<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/NCT04401813</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI310C101</org_study_id>
    <nct_id>NCT04401813</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma</brief_title>
  <official_title>An Open-label, Single-arm, Phase Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovent Biologics (Suzhou) Co. Ltd.</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>
      An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with&#xD;
      sintilimab in patients with advanced hepatocellular carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, approximately 18 to 47 patients who have previously received sorafenib,&#xD;
      lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310,&#xD;
      the study will enter the expansion phase&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>Phase 1</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>adverse event</measure>
    <time_frame>21-42days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma</measure>
    <time_frame>21-42days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1).</measure>
    <time_frame>1years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Advanced Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>IBI310</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBI308 200mg</intervention_name>
    <description>Received IBI310 combined with sintilizumab 200mg</description>
    <arm_group_label>IBI310</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria：&#xD;
&#xD;
          1. Locally advanced or metastatic hepatocellular carcinoma, confirmed by&#xD;
             histology/cytology.&#xD;
&#xD;
          2. Disease progression after surgery and / or local treatment.&#xD;
&#xD;
          3. Previous standard systemic treatments for advanced hepatocellular carcinoma have&#xD;
             failed or developed intolerable toxicity.&#xD;
&#xD;
        exclusion criteria：&#xD;
&#xD;
          1. Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid&#xD;
             hepatocellular carcinoma, cholangiocarcinoma and other components.&#xD;
&#xD;
          2. Have a history of hepatic encephalopathy, or have a history of liver transplantation.&#xD;
&#xD;
          3. Diffuse liver cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</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>
  <!-- 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/NCT04401813
org study id: CIBI310C101
nct id: NCT04401813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with
      sintilimab in patients with advanced hepatocellular carcinoma
In this study, approximately 18 to 47 patients who have previously received sorafenib,
      lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310,
      the study will enter the expansion phase
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: adverse event
time frame: 21-42days
measure: Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma
time frame: 21-42days
measure: Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1).
time frame: 1years
arm group label: IBI310
arm group type: Experimental
description: An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
intervention type: Drug
intervention name: IBI308 200mg
description: Received IBI310 combined with sintilizumab 200mg
arm group label: IBI310
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular