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/NCT05970666</url>
    </required_header>
    <id_info>
      <org_study_id>23-OBU-FJ-HCC-II-012</org_study_id>
      <nct_id>NCT05970666</nct_id>
    </id_info>
    <brief_title>Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma</brief_title>
    <official_title>Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Xiamen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The First Affiliated Hospital of Xiamen University</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 evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab&#xD;
        transformation in unresectable hepatocellular carcinoma&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</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>Objective response rate（ORR）</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurence of AE and SAE</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radical (R0) resection rate after conversion therapy</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The cut margin had no residual cancer cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>percent conversion</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The ates of conversion to operable patients in inoperable patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological complete response rate (pCR)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The rate of no remaining tumor cells in the excised tissue samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major pathological response rate (MPR)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The ratio of the tumor cells active in the removed tissue samples is less than 10%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate（DCR）</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse-free survival time (RFS)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Time from date of cure surgery to time of recurrence or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival（OS）</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Defined as the time from the date of the first dose to the death of the subject from any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">71</enrollment>
    <condition>Adebrelimab</condition>
    <condition>Hepatocellular Carcinoma</condition>
    <condition>Transformation</condition>
    <condition>Bevacizumab</condition>
    <condition>TACE</condition>
    <arm_group>
      <arm_group_label>Single arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TACE with adebrelimab and bevacizumab</intervention_name>
      <description>TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);</description>
      <arm_group_label>Single arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 18 ~ 75, both male and female；&#xD;
  &#xD;
            2. Strictly comply with the primary liver cancer diagnosis and treatment standard (2022&#xD;
               edition) clinical diagnosis criteria or primary hepatocellular carcinoma diagnosed by&#xD;
               pathological histology or cytology examination, and at least one measurable lesions&#xD;
               (according to the RECIST1.1 standard, the spiral CT scan of 10mm or short diameter of&#xD;
               15mm）；&#xD;
  &#xD;
            3. Patients without previous systematic treatment and inoperable resection / radical&#xD;
               ablation surgery, but who can tolerate TACE;&#xD;
  &#xD;
            4. The CNLC stage is Ⅱa-Ⅲb stage;&#xD;
  &#xD;
            5. The Child-Pugh grade of liver function is A grade or B grade (5-7 points);&#xD;
  &#xD;
            6. The ECOG PS score is 0-1 points;&#xD;
  &#xD;
            7. Expected survival period of 12 weeks;&#xD;
  &#xD;
            8. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid&#xD;
               (DNA) must be &lt;2000 IU / mL (if the study site has only copy / mL testing units, Must&#xD;
               be &lt;12500 copy / mL), And received at least 14 days before initiating anti-HBV&#xD;
               treatment (according to local standard therapy, e. g. entecavir) and willing to&#xD;
               receive antiviral treatment throughout the study; hepatitis C virus (HCV) ribonucleic&#xD;
               acid (RNA) positive patients must receive antiviral treatment according to local&#xD;
               standard treatment guidelines and liver function within grade CTCAE 1 elevation;&#xD;
  &#xD;
            9. Main organs function are normal and meet the following criteria: (1) The blood routine&#xD;
               examination standards should be met with: (no blood transfusion within 14 days) A.&#xD;
               Hemoglobin (HB), 90g / L, B. White blood cell count (WBC) 3109 / L C. Absolute&#xD;
               neutrophil count (ANC) 1.5109 / L, D. Platelet (PLT) 80109 / L;(2) Biochemical&#xD;
               examination shall meet the following standards: A. Bilirubin (BIL) &lt;1.5 times the&#xD;
               upper limit of normal value (ULN); B. Glutamic gamma aminotransferase (ALT) and&#xD;
               glutamate aminotransferase AST &lt;5 ULN; C. Serum creatinine (Cr)≤1.5ULN；&#xD;
  &#xD;
           10. Women of childbearing age must have negative pregnancy test (serum) or urine HCG&#xD;
               within 7 days before enrollment and are willing to use appropriate contraception&#xD;
               during treatment and 24 weeks after the last administration of test drug; for men,&#xD;
               surgical sterilization or agree to use appropriate contraception during and 24 weeks&#xD;
               after the last administration of trial drug;&#xD;
  &#xD;
           11. The subjects volunteered to join the study and had good compliance with the follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or lactating women;&#xD;
  &#xD;
            2. The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;&#xD;
  &#xD;
            3. Diffuse liver cancer;&#xD;
  &#xD;
            4. Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or&#xD;
               other malignant tumors (except for cured basal skin cell carcinoma and cervix&#xD;
               carcinoma in situ);&#xD;
  &#xD;
            5. Patients with consciousness disorders or unable to cooperate with the treatment,&#xD;
               combined with patients with mental illness;&#xD;
  &#xD;
            6. Patients who have participated in other clinical trials in the recent three months;&#xD;
  &#xD;
            7. Previous history of other malignancies or have received targeted therapy and other&#xD;
               PD-1 / PD-L1 inhibitor therapy;&#xD;
  &#xD;
            8. Received major surgery or chemotherapy or other systemic therapy for target lesions&#xD;
               (including not limited to radiation therapy, ablation therapy, etc.) within 1 month&#xD;
               prior to enrollment;&#xD;
  &#xD;
            9. Use of immunosuppressants or systemic hormone therapy within 14 days before enrollment&#xD;
               to achieve immunosuppressive purposes (dose&gt; 10mg / day prednisone or other efficacy&#xD;
               hormones);&#xD;
  &#xD;
           10. Liver function was graded as Child-Pugh C, which could not be improved by liver care&#xD;
               treatment；&#xD;
  &#xD;
           11. esophageal (gastric fundus) varices rupture and bleeding within 1 month before&#xD;
               treatment；&#xD;
  &#xD;
           12. Uncorrectable coagulopathy and severe blood abnormalities, with severe bleeding&#xD;
               tendency. Platelet count &lt;50109 / L and severe coagulation abnormalities against&#xD;
               surgery (anticoagulation therapy and / or anticoagulant therapy should be stopped for&#xD;
               more than 1 week before radiation therapy);&#xD;
  &#xD;
           13. A stubborn amount of ascites, pleural fluid, malignant fluid;&#xD;
  &#xD;
           14. Active infection, especially the inflammation of the biliary tract system;&#xD;
  &#xD;
           15. Severe functional failure of the liver, kidney, heart, lung, brain and other major&#xD;
               organs;&#xD;
  &#xD;
           16. Previously allergic to PD-1 / PD-L1 mAb / any component of the targeted drug or other&#xD;
               similar trials;&#xD;
  &#xD;
           17. Patients with hypertension who cannot be reduced to the normal range by&#xD;
               antihypertensive medication (systolic blood pressure&gt; 140 mmHg, diastolic blood&#xD;
               pressure&gt; 90 mmHg);&#xD;
  &#xD;
           18. Previous severe cardiovascular disease, including but not limited to the following&#xD;
               diseases: myocardial ischemia or myocardial infarction, poorly controlled arrhythmia&#xD;
               (including 450 ms in QTc men and 470 ms in women); cardiac dysfunction by NYHA, or&#xD;
               cardiac ultrasound indicating left ventricular ejection fraction (LVEF) &lt;50%;&#xD;
  &#xD;
           19. Patients with positive urinary protein (urinary protein test of 2 + or above, or&#xD;
               24-hour urinary protein quantification of&gt; 1.0g);&#xD;
  &#xD;
           20. Failure to swallow tablets, malabsorption syndrome, or any condition affecting&#xD;
               gastrointestinal absorption;&#xD;
  &#xD;
           21. According to the discretion of the investigator, patients with other concomitant&#xD;
               diseases that seriously endanger patient safety or affect the completion of the study;&#xD;
  &#xD;
           22. Patients with radiotherapy, targeted therapy, and other contraindications to&#xD;
               immunotherapy.&#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>Jianbo Chen</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Feng Ye</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>congren Wang</last_name>
      <role>Study Director</role>
      <affiliation>Quanzhou First Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qinghe Cai</last_name>
      <role>Study Director</role>
      <affiliation>Affiliated Hospital of Putian University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jiafei Chen</last_name>
      <role>Study Director</role>
      <affiliation>Putian First Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yongzhong Wang</last_name>
      <role>Study Director</role>
      <affiliation>Sanming Second Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Feng Lin</last_name>
      <role>Study Director</role>
      <affiliation>Ningde Mindong Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jianbo Chen</last_name>
      <phone>15605921022</phone>
      <email>274439002@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xiamen University</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jianbo Chen</last_name>
        <phone>15605921022</phone>
        <email>274439002@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Xiamen University</investigator_affiliation>
      <investigator_full_name>Jianbo Chen</investigator_full_name>
      <investigator_title>director</investigator_title>
    </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>
    </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/NCT05970666
  org study id: 23-OBU-FJ-HCC-II-012
  nct id: NCT05970666
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab
        transformation in unresectable hepatocellular carcinoma
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate（ORR）
  time frame: Up to 2 years
  description: Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.
  measure: Occurence of AE and SAE
  time frame: Up to 2 years
  description: Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
  measure: Radical (R0) resection rate after conversion therapy
  time frame: Up to 2 years
  description: The cut margin had no residual cancer cells
  measure: percent conversion
  time frame: Up to 2 years
  description: The ates of conversion to operable patients in inoperable patients
  measure: Pathological complete response rate (pCR)
  time frame: Up to 2 years
  description: The rate of no remaining tumor cells in the excised tissue samples
  measure: Major pathological response rate (MPR)
  time frame: Up to 2 years
  description: The ratio of the tumor cells active in the removed tissue samples is less than 10%.
  measure: Progression-free survival (PFS)
  time frame: Up to 2 years
  description: PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.
  measure: Disease control rate（DCR）
  time frame: Up to 2 years
  description: Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD).
  measure: Relapse-free survival time (RFS)
  time frame: Up to 2 years
  description: Time from date of cure surgery to time of recurrence or death
  measure: Overall survival（OS）
  time frame: Up to 2 years
  description: Defined as the time from the date of the first dose to the death of the subject from any cause.
  arm group label: Single arm
  arm group type: Experimental
  intervention type: Drug
  intervention name: TACE with adebrelimab and bevacizumab
  description: TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);
  arm group label: Single arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jianbo Chen
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Xiamen University
  last name: Feng Ye
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Xiamen University
  last name: congren Wang
  role: Study Director
  affiliation: Quanzhou First Hospital
  last name: Qinghe Cai
  role: Study Director
  affiliation: Affiliated Hospital of Putian University
  last name: Jiafei Chen
  role: Study Director
  affiliation: Putian First Hospital
  last name: Yongzhong Wang
  role: Study Director
  affiliation: Sanming Second Hospital
  last name: Feng Lin
  role: Study Director
  affiliation: Ningde Mindong Hospital
  last name: Jianbo Chen
  phone: 15605921022
  email: 274439002@qq.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital of Xiamen University
  investigator full name: Jianbo Chen
  investigator title: director
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Bevacizumab