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/NCT06040177</url>
    </required_header>
    <id_info>
      <org_study_id>GuangxiMUMJ1</org_study_id>
      <nct_id>NCT06040177</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus</brief_title>
    <official_title>Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Guangxi Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Guangxi Medical University</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>
        This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of&#xD;
        SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable&#xD;
        hepatocellular carcinoma with portal vein tumor thrombus&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 2, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Actual">February 2, 2023</primary_completion_date>
    <phase>Phase 1/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 approximately 2 years</time_frame>
      <description>ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>3-month PFS rate</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>progression-free survival (PFS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Duration of Response (DOR) is defined as the time between the first assessment of a tumor as Complete Response（CR）or Partial Response（PR）and the first assessment of Progressive Disease (PD) or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Hepatocellular Carcinoma Non-resectable</condition>
    <condition>Portal Vein Tumor Thrombus</condition>
    <condition>Immune Checkpoint Inhibitors</condition>
    <arm_group>
      <arm_group_label>SBRT+cardonilizumab+lenvastinib Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Renvatinib: 8mg (weight &lt;60kg) or 12mg (weight ≥60kg) once a day until disease progression, intolerable toxicity Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cadonilimab</intervention_name>
      <description>Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years</description>
      <arm_group_label>SBRT+cardonilizumab+lenvastinib Group</arm_group_label>
      <other_name>AK104</other_name>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Stereotactic radiotherapy</intervention_name>
      <description>Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry</description>
      <arm_group_label>SBRT+cardonilizumab+lenvastinib Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Renvatinib</intervention_name>
      <description>Renvatinib: 8mg (weight &lt;60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity</description>
      <arm_group_label>SBRT+cardonilizumab+lenvastinib Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 18-70 years old;&#xD;
  &#xD;
            2. Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-2 points；&#xD;
  &#xD;
            3. Hepatocellular carcinoma was diagnosed according to histopathology or the 2022&#xD;
               diagnostic criteria for primary liver cancer；&#xD;
  &#xD;
            4. Expected survival period≥3 months;&#xD;
  &#xD;
            5. Liver function grade Child-Pugh A or better grade B (7 points);&#xD;
  &#xD;
            6. At least one measurable lesion:&#xD;
  &#xD;
               Liver lesion ① The Lesion can be accurately measured at least in the range of 1.0cm;&#xD;
  &#xD;
               ② The Lesion is suitable for repeated measurement;&#xD;
  &#xD;
                 -  The lesion shows enhanced intratumoral arteries on computed tomography (CT) or&#xD;
                    magnetic resonance imaging (MRI); Non-liver lesion In at least one dimension, the&#xD;
                    short axis of lymphadenopathy (LN) is≥1.5cm. Longest diameter of non-nodular&#xD;
                    lesions is≥1.0cm&#xD;
  &#xD;
            7. The Barcelona liver cancer staging system is stage C (BCLC-C), which meets one of the&#xD;
               following conditions:&#xD;
  &#xD;
          (1) Liver tumor can be resected, which is combined with Vp 3-4 portal vein cancer thrombus;&#xD;
          (2) Liver tumor is unresectable or has distant metastasis, and is combined with Vp1-4 type&#xD;
          portal vein cancer thrombus; 8. The patient had not received prior systemic therapy&#xD;
          including sorafenib, lenvatinib, chemotherapy; 9. The patient had previously received&#xD;
          locoregional therapy (including radiofrequency or ablation therapy, percutaneous ethanol or&#xD;
          acetic acid injection, cryotherapy, high intensity focused ultrasound, hepatic artery&#xD;
          chemoembolization, hepatic artery embolization, etc., and the local treatment area had&#xD;
          definite progression (according to RECIST v1.1 criteria); 10. Baseline blood routine and&#xD;
          biochemical indicators meet the following criteria: Hemoglobin≥90g / L; Absolute neutrophil&#xD;
          count (ANC)≥1.5× 10 ^ 9 / L; Platelet≥75×10 ^ 9 / L; ALT,AST ≤3×upper normal value (ULN);&#xD;
          Serum total bilirubin ≤ 1.5 ×ULN; Serum creatinine ≤1.5 × ULN; Serum albumin was used&#xD;
          for≥30g / L.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with hepatobiliary duct cell carcinoma, mixed cell carcinoma, or&#xD;
               fibrolaminar cell carcinoma；&#xD;
  &#xD;
            2. Patients with a history of allogeneic organ transplantation or allogeneic&#xD;
               hematopoietic stem cell transplantation or planned transplantation；&#xD;
  &#xD;
            3. Patients have hepatic encephalopathy (West Haven Standard Grade III, Level IV) or have&#xD;
               moderate or severe ascites (i.e., patients requiring therapeutic puncture drainage) or&#xD;
               have uncontrolled pleural or pericardial effusion；&#xD;
  &#xD;
            4. Patients have symptomatic, untreated, or progressive central nervous system (CNS) or&#xD;
               leptomeningeal metastases.If all the following criteria are met, asymptomatic subjects&#xD;
               with treated CNS lesions can be enrolled.&#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_contact>
      <last_name>Ning Mo, professor</last_name>
      <phone>15289662269</phone>
      <email>369895025@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>First Affiliated Hospital of Guangxi Medical University</name>
        <address>
          <city>Nanning</city>
          <state>Guangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ning mo</last_name>
        <phone>15289662269</phone>
        <email>369895025@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Guangxi Medical University</investigator_affiliation>
      <investigator_full_name>Jie Ma</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Hepatocellular Carcinoma</keyword>
    <keyword>portal vein tumor thrombus</keyword>
    <keyword>Immune Checkpoint Inhibitors</keyword>
    <keyword>Efficacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
      <mesh_term>Thrombosis</mesh_term>
    </condition_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/NCT06040177
  org study id: GuangxiMUMJ1
  nct id: NCT06040177
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of
        SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable
        hepatocellular carcinoma with portal vein tumor thrombus
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate(ORR)
  time frame: Up to approximately 2 years
  description: ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
  measure: 3-month PFS rate
  time frame: Up to approximately 2 years
  description: 3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.
  measure: progression-free survival (PFS)
  time frame: Up to approximately 2 years
  description: Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
  measure: Disease control rate (DCR)
  time frame: Up to approximately 2 years
  description: DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.
  measure: Duration of response (DOR)
  time frame: Up to approximately 2 years
  description: Duration of Response (DOR) is defined as the time between the first assessment of a tumor as Complete Response（CR）or Partial Response（PR）and the first assessment of Progressive Disease (PD) or death from any cause.
  measure: Overall Survival (OS)
  time frame: Up to approximately 2 years
  description: Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause
  arm group label: SBRT+cardonilizumab+lenvastinib Group
  arm group type: Experimental
  description: Renvatinib: 8mg (weight <60kg) or 12mg (weight ≥60kg) once a day until disease progression, intolerable toxicity Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years
  intervention type: Drug
  intervention name: Cadonilimab
  description: Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years
  arm group label: SBRT+cardonilizumab+lenvastinib Group
  other name: AK104
  intervention type: Radiation
  intervention name: Stereotactic radiotherapy
  description: Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry
  arm group label: SBRT+cardonilizumab+lenvastinib Group
  intervention type: Drug
  intervention name: Renvatinib
  description: Renvatinib: 8mg (weight <60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity
  arm group label: SBRT+cardonilizumab+lenvastinib Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Ning Mo, professor
  phone: 15289662269
  email: 369895025@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital of Guangxi Medical University
  investigator full name: Jie Ma
  investigator title: Clinical Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Thrombosis