<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/NCT04415567</url>
  </required_header>
  <id_info>
    <org_study_id>XH-20-010</org_study_id>
    <nct_id>NCT04415567</nct_id>
  </id_info>
  <brief_title>Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation</brief_title>
  <official_title>Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With Hepatitis B Virus-related Hepatocellular Carcinoma Following Liver Transplantation: a Retrospective Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinyang Gu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer&#xD;
      from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel&#xD;
      targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is&#xD;
      no study on its effect in preventing HCC recurrence in the patients undergoing&#xD;
      transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing&#xD;
      recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively&#xD;
      analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9)&#xD;
      with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the&#xD;
      two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators retrospectively reviewed 23 Chinese HCC patients with HBV infection, who&#xD;
      underwent LT in our hospital from June 2018 to December 2019. All donor grafts were allocated&#xD;
      by the China Organ Transplant Response System. All these patients were diagnosed by histology&#xD;
      and were defined as &quot;high-risk&quot; for recurrence.&#xD;
&#xD;
      The participants were divided into lenvatinib group and control group according to their&#xD;
      willingness to take lenvatinib as adjuvant therapy after LT. Of the 23 patients, 14 pantients&#xD;
      in lenvatinib group began to take lenvatinib about a month after LT except for routine&#xD;
      treatment, while the other 9 patients in control group received routine treatment and&#xD;
      follow-up after transplantation. Clinical data and demographic characteristics was obtained.&#xD;
      This study was conducted according to the 1975 Declaration of Helsinki and approved by Ethics&#xD;
      Committee of Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine&#xD;
      (No. XHEC-D-2020-068). All patients enrolled in this study provided informed consent.&#xD;
&#xD;
      Usage of lenvatinib and immunosuppressants The participants in lenvatinib group received oral&#xD;
      lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW &lt;60 kg)&#xD;
      in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary&#xD;
      withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8&#xD;
      mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for&#xD;
      more than 3 cycles.&#xD;
&#xD;
      The induction immunosuppression strategies for all participants enrolled in the study&#xD;
      involved IV infusion of 20mg of basiliximab within 2 hours prior to operation and a second&#xD;
      dose 4 days later, oral tacrolimus started on the fourth day after LT at a dose of 0.04mg/kg&#xD;
      (BW) and adjusted according to its plasma concentration, taking mycophenolate mofetil (MMF)&#xD;
      from the next day after surgery at a dose of 500mg/kg(BW), and rapid withdrawal of&#xD;
      glucocorticoids with the initial dose of 500mg. Maintenance immunosuppression which was&#xD;
      started about one month after LT included sirolimus (4 mg/M2 per day) plus oral tacrolimus&#xD;
      with the plasma concentration maintained at 5-8 ng/ml.&#xD;
&#xD;
      All patients were followed up monthly within six months after LT and every three months&#xD;
      within two years. During each follow-up, complete blood count, urinalysis, serum AFP level,&#xD;
      liver and kidney function test, and blood concentration of FK506 were recorded. Chest and&#xD;
      abdominal computed tomography was implemented at 3 months, 6 months, 12 months, and annually&#xD;
      thereafter. Other radiological examinations such as radionuclide bone scan, magnetic&#xD;
      resonance imaging (MRI) and positron emission tomography (PET) were obtained when local&#xD;
      recurrence or distant metastasis was suspected.&#xD;
&#xD;
      The DFS was defined as the period between the day of LT and the day of HCC recurrence&#xD;
      confirmed by imaging, while the OS was defined as the duration from LT to death of patients&#xD;
      for any reason or to end of follow-up. Common terminology criteria for adverse events version&#xD;
      5.0 (CTCAE V5.0) was used to assess the AE during oral administration of lenvatinib. The&#xD;
      FK506 dosage and blood concentration of each patients in the first six months after liver LT&#xD;
      was recorded for evaluate the influence of lenvatinib on the immunosuppressive therapy.&#xD;
&#xD;
      Mean and standard deviations were used for descriptive statistics. The patient&#xD;
      characteristics in each group were compared by one-way ANOVA and chi-square tests. Repeated&#xD;
      measures analysis of variances was used for comparing the difference of FK506 dosage and&#xD;
      blood concentration between two groups. The OS and DFS were statistically analyzed by the&#xD;
      Kaplan-Meier method. Statistical significance was set at P&lt;0.05. All statistical analyses&#xD;
      were performed using SPSS software Version 10.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>The disease-free survival (DFS) was defined as the period between the day of LT and the day of HCC recurrence confirmed by imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>The overall survival (OS) was defined as the period between the day of LT and the day of the participants' death or the termination of the study in 3 years after LT.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>3-year Recurrence rate (RR)</measure>
    <time_frame>3 years</time_frame>
    <description>The 3-year recurrence rate is obtained by dividing the number of recurrence cases in each group by the total number of cases in each group.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>lenvatinib</arm_group_label>
    <description>high-risk patients with HBV-related HCC who took lenvatinib as adjuvant therapy after liver transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>high-risk patients with HBV-related HCC who received routine treatment and follow-up after liver transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>The patients in lenvatinib group received oral lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW &lt;60 kg) in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8 mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for more than 3 cycles.</description>
    <arm_group_label>lenvatinib</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The cohorts in the study involved the patients who underwent liver transplantation for&#xD;
        HBV-related HCC and were diagnosed as &quot;high-risk&quot; for recurrence according the above&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The recipients who underwent liver transplantation with the pathologic diagnosis of&#xD;
             hepatocellular carcinoma.&#xD;
&#xD;
          2. The extrahepatic metastasis was excluded preoperatively.&#xD;
&#xD;
          3. The patients were defined as &quot;high-risk&quot; for recurrence according to the following&#xD;
             criteria:&#xD;
&#xD;
        (1) beyond Milan criteria confirmed either by radiology before LT or by pathology after LT,&#xD;
        (2) tumor with intrahepatic vascular invasion, (3) Alpha-fetoprotein (AFP)≥400ng/L before&#xD;
        LT, (4) presence of microvascular invasion (MVI), (5) tumor with histological poor&#xD;
        differentiation according to Edmondson-Steiner classification system(21), (6) multiple&#xD;
        satellite lesions around the largest tumors detected either by radiology before LT or by&#xD;
        histology after LT, (7) tumor penetrating hepatic capsule, (8) recurrent HCC after&#xD;
        resection. 4. ECOG score between 0-1 within 1 week before took lenvatinib. 5. The patients&#xD;
        have received regular antiviral treatment. 6. Life expectancy more than 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients took lenvatinib before liver transplantation and assessed as SD or PD&#xD;
             according to the mRECIST criteria.&#xD;
&#xD;
          2. The patients suffered from other incurable malignancies within 5 years or at the same&#xD;
             time.&#xD;
&#xD;
          3. Distant metastasis of tumor was confirmed by imaging before or within 1 month after&#xD;
             transplantation.&#xD;
&#xD;
          4. The patients have not received regular antiviral treatment.&#xD;
&#xD;
          5. The patients had a history of mental illness or abuse of psychoactive drugs.&#xD;
&#xD;
          6. The patients deemed unsuitable by attending doctors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinyang Gu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.</citation>
    <PMID>29433850</PMID>
  </results_reference>
  <results_reference>
    <citation>Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.</citation>
    <PMID>32265508</PMID>
  </results_reference>
  <results_reference>
    <citation>Siegel AB, El-Khoueiry AB, Finn RS, Guthrie KA, Goyal A, Venook AP, Blanke CD, Verna EC, Dove L, Emond J, Kato T, Samstein B, Busuttil R, Remotti H, Coffey A, Brown RS Jr. Phase I trial of sorafenib following liver transplantation in patients with high-risk hepatocellular carcinoma. Liver Cancer. 2015 Mar;4(2):115-25. doi: 10.1159/000367734.</citation>
    <PMID>26020033</PMID>
  </results_reference>
  <results_reference>
    <citation>Teng CL, Hwang WL, Chen YJ, Chang KH, Cheng SB. Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study. World J Surg Oncol. 2012 Feb 17;10:41. doi: 10.1186/1477-7819-10-41.</citation>
    <PMID>22339891</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jinyang Gu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>liver transplantation</keyword>
  <keyword>lenvatinib</keyword>
  <keyword>adjuvant therapy</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>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenvatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The IPDs to be shared include study protocol, statistical analysis methods, informed consent form and clinical study report.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will become available from the manuscript accepted by a journal to five years after that.</ipd_time_frame>
    <ipd_access_criteria>The data will become available when the manuscript accepted by a journal, until five years after that.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04415567
org study id: XH-20-010
nct id: NCT04415567
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer
      from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel
      targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is
      no study on its effect in preventing HCC recurrence in the patients undergoing
      transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing
      recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively
      analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9)
      with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the
      two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were
      evaluated.
The investigators retrospectively reviewed 23 Chinese HCC patients with HBV infection, who
      underwent LT in our hospital from June 2018 to December 2019. All donor grafts were allocated
      by the China Organ Transplant Response System. All these patients were diagnosed by histology
      and were defined as "high-risk" for recurrence.

      The participants were divided into lenvatinib group and control group according to their
      willingness to take lenvatinib as adjuvant therapy after LT. Of the 23 patients, 14 pantients
      in lenvatinib group began to take lenvatinib about a month after LT except for routine
      treatment, while the other 9 patients in control group received routine treatment and
      follow-up after transplantation. Clinical data and demographic characteristics was obtained.
      This study was conducted according to the 1975 Declaration of Helsinki and approved by Ethics
      Committee of Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      (No. XHEC-D-2020-068). All patients enrolled in this study provided informed consent.

      Usage of lenvatinib and immunosuppressants The participants in lenvatinib group received oral
      lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW <60 kg)
      in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary
      withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8
      mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for
      more than 3 cycles.

      The induction immunosuppression strategies for all participants enrolled in the study
      involved IV infusion of 20mg of basiliximab within 2 hours prior to operation and a second
      dose 4 days later, oral tacrolimus started on the fourth day after LT at a dose of 0.04mg/kg
      (BW) and adjusted according to its plasma concentration, taking mycophenolate mofetil (MMF)
      from the next day after surgery at a dose of 500mg/kg(BW), and rapid withdrawal of
      glucocorticoids with the initial dose of 500mg. Maintenance immunosuppression which was
      started about one month after LT included sirolimus (4 mg/M2 per day) plus oral tacrolimus
      with the plasma concentration maintained at 5-8 ng/ml.

      All patients were followed up monthly within six months after LT and every three months
      within two years. During each follow-up, complete blood count, urinalysis, serum AFP level,
      liver and kidney function test, and blood concentration of FK506 were recorded. Chest and
      abdominal computed tomography was implemented at 3 months, 6 months, 12 months, and annually
      thereafter. Other radiological examinations such as radionuclide bone scan, magnetic
      resonance imaging (MRI) and positron emission tomography (PET) were obtained when local
      recurrence or distant metastasis was suspected.

      The DFS was defined as the period between the day of LT and the day of HCC recurrence
      confirmed by imaging, while the OS was defined as the duration from LT to death of patients
      for any reason or to end of follow-up. Common terminology criteria for adverse events version
      5.0 (CTCAE V5.0) was used to assess the AE during oral administration of lenvatinib. The
      FK506 dosage and blood concentration of each patients in the first six months after liver LT
      was recorded for evaluate the influence of lenvatinib on the immunosuppressive therapy.

      Mean and standard deviations were used for descriptive statistics. The patient
      characteristics in each group were compared by one-way ANOVA and chi-square tests. Repeated
      measures analysis of variances was used for comparing the difference of FK506 dosage and
      blood concentration between two groups. The OS and DFS were statistically analyzed by the
      Kaplan-Meier method. Statistical significance was set at P<0.05. All statistical analyses
      were performed using SPSS software Version 10.0.
observational model: Case-Control
time perspective: Retrospective
measure: Disease-free survival (DFS)
time frame: up to 3 years
description: The disease-free survival (DFS) was defined as the period between the day of LT and the day of HCC recurrence confirmed by imaging.
measure: Overall survival (OS)
time frame: up to 3 years
description: The overall survival (OS) was defined as the period between the day of LT and the day of the participants' death or the termination of the study in 3 years after LT.
measure: 3-year Recurrence rate (RR)
time frame: 3 years
description: The 3-year recurrence rate is obtained by dividing the number of recurrence cases in each group by the total number of cases in each group.
arm group label: lenvatinib
description: high-risk patients with HBV-related HCC who took lenvatinib as adjuvant therapy after liver transplantation
arm group label: control
description: high-risk patients with HBV-related HCC who received routine treatment and follow-up after liver transplantation
intervention type: Drug
intervention name: Lenvatinib
description: The patients in lenvatinib group received oral lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW <60 kg) in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8 mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for more than 3 cycles.
arm group label: lenvatinib
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 69 Years
healthy volunteers: No
last name: Jinyang Gu, PhD
role: Principal Investigator
affiliation: Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School
facility: 
country: China
citation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
PMID: 29433850
citation: Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.
PMID: 32265508
citation: Siegel AB, El-Khoueiry AB, Finn RS, Guthrie KA, Goyal A, Venook AP, Blanke CD, Verna EC, Dove L, Emond J, Kato T, Samstein B, Busuttil R, Remotti H, Coffey A, Brown RS Jr. Phase I trial of sorafenib following liver transplantation in patients with high-risk hepatocellular carcinoma. Liver Cancer. 2015 Mar;4(2):115-25. doi: 10.1159/000367734.
PMID: 26020033
citation: Teng CL, Hwang WL, Chen YJ, Chang KH, Cheng SB. Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study. World J Surg Oncol. 2012 Feb 17;10:41. doi: 10.1186/1477-7819-10-41.
PMID: 22339891
responsible party type: Sponsor-Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Jinyang Gu
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Recurrence
mesh term: Lenvatinib
sharing ipd: Yes
ipd description: The IPDs to be shared include study protocol, statistical analysis methods, informed consent form and clinical study report.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will become available from the manuscript accepted by a journal to five years after that.
ipd access criteria: The data will become available when the manuscript accepted by a journal, until five years after that.