<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/NCT04483284</url>
  </required_header>
  <id_info>
    <org_study_id>MA-HCC-Ⅱ-003</org_study_id>
    <nct_id>NCT04483284</nct_id>
  </id_info>
  <brief_title>Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients</brief_title>
  <official_title>Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan 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>
      It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE&#xD;
      combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment&#xD;
      will continue until disease progression or intolerable toxicity or patients withdrawal of&#xD;
      consent,and the target sample size is 60 individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center and single-arm exploratory clinical study designed to&#xD;
      evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of&#xD;
      patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until&#xD;
      disease progression or intolerable toxicity or patients withdrawal of consent,and the target&#xD;
      sample size is 60 individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Progression Free Survival</measure>
    <time_frame>an expected average of 8 months</time_frame>
    <description>the time from enrollment to the first disease progression or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>An expected average of 8 months</time_frame>
    <description>the time from enrollment to the first disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>An expected average of 24 months</time_frame>
    <description>the time from enrollment to the death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>An expected average of 8 months</time_frame>
    <description>evaluated by investigators with mRECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>An expected average of 8 months</time_frame>
    <description>evaluated by investigators with mRECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>An expected average of 8 months</time_frame>
    <description>evaluated by investigators with mRECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of AEs and SAEs by NCI-CTCAE v5.0</measure>
    <time_frame>An expected average of 8 months</time_frame>
    <description>Safety index</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>TACE combined with Camrelizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Camrelizumab（200mg q3w ivgtt）combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TACE combined with Camrelizumab</intervention_name>
    <description>Camrelizumab(200mg q3w ivgtt) combined with TACE</description>
    <arm_group_label>TACE combined with Camrelizumab</arm_group_label>
    <other_name>TACE plus Camrelizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE plus Camrelizumab</intervention_name>
    <description>Camrelizumab(200mg q3w ivgtt) combined with TACE</description>
    <arm_group_label>TACE combined with Camrelizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Patients voluntarily entered the study and signed informed consent form (ICF) 2.&#xD;
             Age: 18 - 80 years old and life expectancy of at least 12 weeks.; 3. Clinically or&#xD;
             histologically diagnosed as HCC; 4. There are measurable lesions that meet the&#xD;
             RECIST1.1 standard on the baseline imaging examination; 5. Child-pugh classification A&#xD;
             or B (score &lt; 7); 6. The BCLC stage is stage B or C, and it is unable or unwilling to&#xD;
             undergo surgical treatment; 7. ECOG : 0 ~ 1 ; 8. No previous immune checkpoint&#xD;
             inhibitor treatment (including PD-1 / PD-L1 antibody and CTLA-4 inhibitor); 9.&#xD;
             HBV-deoxyribonucleic acid (DNA) must be &lt;500IU / mL, and receive at least 14 days of&#xD;
             anti-HBV treatment before the start of study treatment Treatment;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. History of treatment with any local treatment (exception of liver transplantation),&#xD;
             systemic .anti-cancer therapy, or immunotherapy; 2. Those whose tumor thrombus reaches&#xD;
             or exceeds the main portal vein; 3. Existing or concurrently suffering from other&#xD;
             malignant tumors, except for fully treated non-melanoma skin cancer, cervical&#xD;
             carcinoma in situ, and papillary thyroid carcinoma; 4. There is any active autoimmune&#xD;
             disease or has a history of autoimmune disease and may relapse; 5. Use strong CYP3A4 /&#xD;
             CYP2C19 inducers including rifampicin and Hypericum perforatum or strong CYP3A4 /&#xD;
             CYP2C19 inhibitors within 14 days before starting the study treatment; 6. Known&#xD;
             history of severe allergy to any monoclonal antibody; 7. Patients who are going to&#xD;
             undergo or have undergone organ or allogeneic bone marrow transplantation; 8.&#xD;
             Non-compliance with TACE or Camrelizumab; 9. Moderate and severe ascites with clinical&#xD;
             symptoms require therapeutic puncture, drainage, or Childa-Pugh score&gt; 2 (except&#xD;
             imaging only shows a small amount of ascites but not accompanied by clinical&#xD;
             symptoms); uncontrolled or moderate and Above pleural effusion and pericardial&#xD;
             effusion; 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess&#xD;
             occurred within 6 months before the start of the study treatment; 11. Thrombosis or&#xD;
             embolism occurred within 6 months before the start of study treatment, such as&#xD;
             cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage,&#xD;
             cerebral infarction, pulmonary embolism, etc.) 12. Known inherited or acquired&#xD;
             bleeding or thrombophilia ; currently or recently (10 days prior to the start of study&#xD;
             treatment) have used full dose oral or Injection of anticoagulant drugs or&#xD;
             thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight&#xD;
             heparin); 13. Major vascular disease within 6 months before the study treatment; 22.&#xD;
             Past or present central nervous system metastasis; 14. Metastatic diseases involving&#xD;
             major airways or blood vessels or a large mediastinal tumor mass in the center (&lt;30 mm&#xD;
             from the crest) 15. Those with a history of hepatic encephalopathy; 16. Palliative&#xD;
             radiotherapy for non-target lesions allowed for symptom control must be completed at&#xD;
             least 2 weeks before the start of study treatment. Adverse events caused by&#xD;
             radiotherapy have not recovered to ≤CTCAE level 1; 17. There were severe infections&#xD;
             within 4 weeks before starting the study treatment; 18. Patients with congenital or&#xD;
             acquired immune deficiency (such as those infected with HIV); 19. Co-infection with&#xD;
             hepatitis B and C; 20. For patients with bone metastases, the palliative radiotherapy&#xD;
             area&gt; 5% bone marrow area received within 4 weeks before participating in the study;&#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>Yan zhiping, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Interventional Radiology, Zhongshan Hospital, Fudan University.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2021</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>Chlorotrianisene</mesh_term>
  </intervention_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/NCT04483284
org study id: MA-HCC-Ⅱ-003
nct id: NCT04483284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE
      combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment
      will continue until disease progression or intolerable toxicity or patients withdrawal of
      consent,and the target sample size is 60 individuals.
This is a prospective, single-center and single-arm exploratory clinical study designed to
      evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of
      patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until
      disease progression or intolerable toxicity or patients withdrawal of consent,and the target
      sample size is 60 individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: an expected average of 8 months
description: the time from enrollment to the first disease progression or death from any cause
measure: Time to progression
time frame: An expected average of 8 months
description: the time from enrollment to the first disease progression
measure: Overall survival
time frame: An expected average of 24 months
description: the time from enrollment to the death from any cause
measure: Objective response rate
time frame: An expected average of 8 months
description: evaluated by investigators with mRECIST
measure: Disease control rate
time frame: An expected average of 8 months
description: evaluated by investigators with mRECIST
measure: Duration of response
time frame: An expected average of 8 months
description: evaluated by investigators with mRECIST
measure: The incidence of AEs and SAEs by NCI-CTCAE v5.0
time frame: An expected average of 8 months
description: Safety index
arm group label: TACE combined with Camrelizumab
arm group type: Experimental
description: Camrelizumab（200mg q3w ivgtt）combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.
intervention type: Drug
intervention name: TACE combined with Camrelizumab
description: Camrelizumab(200mg q3w ivgtt) combined with TACE
arm group label: TACE combined with Camrelizumab
other name: TACE plus Camrelizumab
intervention type: Procedure
intervention name: TACE plus Camrelizumab
description: Camrelizumab(200mg q3w ivgtt) combined with TACE
arm group label: TACE combined with Camrelizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yan zhiping, M.D.
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Chlorotrianisene