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/NCT06031285</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-262</org_study_id>
      <nct_id>NCT06031285</nct_id>
    </id_info>
    <brief_title>Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial</brief_title>
    <official_title>Perioperative Sintilimab Plus Bevacizumab Biosimilar and Transarterial Embolization, Hepatic Artery Infusion Chemotherapy (TACE-HAIC) for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus (PVTT): A Phase-2 Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen 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>
        Although resection provided survival benefit for selected HCC patients with PVTT, the&#xD;
        recurrence rate is still high for those patients. It is still unknown whether perioperative&#xD;
        Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the&#xD;
        survival for those patients. We initialed this phase 2 clinical trial to prove the&#xD;
        perioperative therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</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>
      <intervention_model_description>Two cycles of Sinitilimab plus bevacizumab biosimilar and TACE-HAIC were administrated before resection, six months adjuvant Sinitilimab plus bevacizumab biosimilar.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>RFS, recurrence-free survival</measure>
      <time_frame>6 month</time_frame>
      <description>RFS was defined as the time from the date of treatment to that of first recurrence or death.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">43</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Perioperative of Sinitilimab, bevacizumab biosimilar and TACE-HAIC for HCC patients with PVTT</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sintilimab</intervention_name>
      <description>Perioperative Sinitilimab, bevacizumab biosimilar and TACE-HAIC</description>
      <arm_group_label>Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC</arm_group_label>
      <other_name>bevacizumab biosimilar</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinically diagnosed or pathologically confirmed advanced hepatocellular carcinoma&#xD;
               (unresectable or metastatic), at least one measurable focus without local treatment&#xD;
               (according to mRECIST requirements, the measurable focus spiral CT scan length ≥ 10 mm&#xD;
               or enlargement Short diameter of lymph node ≥15 mm); Child-Pugh score ≤ 6 points&#xD;
               (Child-Pugh A); BCLC staging is stage C; PVTT classification is combined with PVTT&#xD;
               (program classification PVTT ≤ 3), and a single lesion in the liver (or multiple&#xD;
               lesions with diameter) ≤ 7cm of primary liver cancer.&#xD;
  &#xD;
          Newly diagnosed patients who have not received targeted therapy or immunotherapy in the&#xD;
          past; ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria); Expected survival period ≥&#xD;
          12 weeks;&#xD;
  &#xD;
          The functions of vital organs meet the following requirements (no blood components, cell&#xD;
          growth factors and other corrective treatment drugs are allowed within 14 days before the&#xD;
          first administration):&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has any active autoimmune disease or a history of autoimmune disease; The&#xD;
               patient is using immunosuppressive agents or systemic hormone therapy to achieve the&#xD;
               purpose of immunosuppression (dose&gt;10mg/day prednisone or other curative hormones),&#xD;
               and continues to use it within 2 weeks before enrollment; The number of system&#xD;
               treatment lines ≥ 2 lines; Severe allergic reaction to other monoclonal antibodies;&#xD;
               Those with a known history of central nervous system metastasis or hepatic&#xD;
               encephalopathy; Patients whose liver tumor burden is greater than 50% of the total&#xD;
               liver volume, or who have received liver transplantation in the past; Ascites with&#xD;
               clinical symptoms, those who need puncture, drainage, or those who have received&#xD;
               ascites drainage within the past 3 months, except those who have only a small amount&#xD;
               of ascites on imaging but not accompanied by clinical symptoms; Suffer from high blood&#xD;
               pressure and cannot be well controlled by antihypertensive drugs (systolic blood&#xD;
               pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Uncontrolled cardiac&#xD;
               clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable&#xD;
               angina pectoris, myocardial infarction occurred within 1 year, clinically significant&#xD;
               supraventricular or ventricular arrhythmia requires treatment or intervention ,&#xD;
               QTc&gt;450ms (male); QTc&gt;470ms (female); Abnormal coagulation function (INR&gt;2.0, PT&gt;16s),&#xD;
               have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and&#xD;
               allow the preventive use of low-dose aspirin and low molecular heparin; Significant&#xD;
               clinically significant bleeding symptoms or clear bleeding tendency occurred within 3&#xD;
               months before randomization, such as pertussis/hemoptysis 2.5ml or more,&#xD;
               gastrointestinal bleeding, esophageal and gastric varices with bleeding risk,&#xD;
               hemorrhagic stomach Ulcer or vasculitis, etc., if the stool occult blood is positive&#xD;
               at the baseline, it can be re-examined. If it is still positive after the&#xD;
               re-examination, a gastroscopy is required. If the gastroscope shows severe esophageal&#xD;
               and gastric varices, it cannot be included in the group (3 before the group) Except&#xD;
               those who have undergone gastroscopy within a month or less to exclude such cases);&#xD;
               Arterial/venous thrombosis events that occurred within 6 months before randomization,&#xD;
               such as cerebrovascular accidents (including temporary ischemic attacks, cerebral&#xD;
               hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Known&#xD;
               genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients,&#xD;
               coagulation dysfunction, thrombocytopenia, etc.); Urine routine test showed urine&#xD;
               protein ≥ ++ and confirmed 24-hour urine protein content&gt; 1.0 g; Patients who have&#xD;
               previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after&#xD;
               the completion of the treatment (last medication) and less than 4 weeks before the&#xD;
               study medication; molecular targeted therapy (including other oral targeted drugs used&#xD;
               in clinical trials) is less than the first study medication &lt;5 drug half-lives, or&#xD;
               patients whose adverse events (except alopecia) caused by previous treatment have not&#xD;
               recovered to ≤ CTCAE level 1;&#xD;
  &#xD;
          The patient suffered from other malignant tumors in the past 3 years or at the same time&#xD;
          (except for cured skin basal cell carcinoma and cervical carcinoma in situ); Patients with&#xD;
          bone metastases who received palliative radiotherapy within 4 weeks before participating in&#xD;
          the study &gt;5% of the bone marrow area; The patient has previously received other anti-PD-1&#xD;
          antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received&#xD;
          apatinib therapy; Live vaccine may be vaccinated less than 4 weeks before study medication&#xD;
          or may be administered during the study period; According to the judgment of the&#xD;
          investigator, the patient has other factors that may affect the results of the study or&#xD;
          cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious&#xD;
          diseases (including mental illness) that require combined treatment, and serious laboratory&#xD;
          tests&#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>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiliang Qiu</last_name>
        <phone>+862087342651</phone>
        <email>qiujl@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yunfei Yuan</investigator_full_name>
      <investigator_title>Professor</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>
    <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/NCT06031285
  org study id: B2023-262
  nct id: NCT06031285
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Although resection provided survival benefit for selected HCC patients with PVTT, the
        recurrence rate is still high for those patients. It is still unknown whether perioperative
        Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the
        survival for those patients. We initialed this phase 2 clinical trial to prove the
        perioperative therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Two cycles of Sinitilimab plus bevacizumab biosimilar and TACE-HAIC were administrated before resection, six months adjuvant Sinitilimab plus bevacizumab biosimilar.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: RFS, recurrence-free survival
  time frame: 6 month
  description: RFS was defined as the time from the date of treatment to that of first recurrence or death.
  arm group label: Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC
  arm group type: Experimental
  description: Perioperative of Sinitilimab, bevacizumab biosimilar and TACE-HAIC for HCC patients with PVTT
  intervention type: Drug
  intervention name: Sintilimab
  description: Perioperative Sinitilimab, bevacizumab biosimilar and TACE-HAIC
  arm group label: Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC
  other name: bevacizumab biosimilar
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yunfei Yuan
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Bevacizumab
  sharing ipd: No