<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/NCT04487067</url>
  </required_header>
  <id_info>
    <org_study_id>ML42243</org_study_id>
    <nct_id>NCT04487067</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista</brief_title>
  <acronym>AMETHISTA</acronym>
  <official_title>A Phase IIIB, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</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 is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety&#xD;
      and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have&#xD;
      received no prior systemic treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">March 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 29, 2024</primary_completion_date>
  <phase>Phase 3</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>Number of Participants With Grade 3-5 NCI CTCAE v.5 Bleeding/Haemorrhage</measure>
    <time_frame>Up to approximately 48 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Overall survival (OS) is defined as the time from initiation of study treatment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Number of participants with adverse events with severity determined according to NCI CTCAE v5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Progression-free survival (PFS) is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Objective response rate (ORR) is defined as a complete or partial response, as determined by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Time to progression (TTP) is defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Duration of response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Progression Survival (PPS)</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Post-progression survival (PPS) is defined as the time from the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Starting Second or Further Lines of Treatment</measure>
    <time_frame>Up to approximately 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire</measure>
    <time_frame>Up to approximately 48 months</time_frame>
    <description>Participant self-reported symptomatic Adverse Events (AEs) using National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Atezolizumab + Bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive atezolizumab 1200 mg intravenous (IV) infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg IV Q3W (dosed in 3-week cycles)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab 1200 mg IV infusion q3w</description>
    <arm_group_label>Atezolizumab + Bevacizumab</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab 15 mg/kg IV Q3W</description>
    <arm_group_label>Atezolizumab + Bevacizumab</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months&#xD;
             from recruitment;&#xD;
&#xD;
          -  Disease that is not amenable to curative surgical and/or locoregional therapies, or&#xD;
             progressive disease after surgical and /or locoregional therapies;&#xD;
&#xD;
          -  No prior systemic therapy for HCC;&#xD;
&#xD;
          -  At least one measurable untreated lesion;&#xD;
&#xD;
          -  Patients who received prior local therapy are eligible provided the target lesion(s)&#xD;
             have not been previously treated with local therapy or the target lesion(s) within the&#xD;
             field of local therapy have subsequently progressed in accordance with RECIST version&#xD;
             1.1;&#xD;
&#xD;
          -  ECOG Performance Status of 0 or 1 within 7 days prior to recruitment;&#xD;
&#xD;
          -  Child-Pugh class A within 7 days prior to recruitment;&#xD;
&#xD;
          -  Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices&#xD;
             (small to large) must be assessed. In case of varices at high risk of bleeding&#xD;
             (corresponding to medium (F2) or large (F3) varices, or F1 varices with cherry red&#xD;
             spots or red wale marking) prophylatic treatment per local standard of care must be&#xD;
             adopted prior to enrollment. Patients who have undergone an EGD within 6 months of&#xD;
             prior to initiation of study treatment do not need to repeat the procedure provided&#xD;
             they had no varices at high risk of bleeding;&#xD;
&#xD;
          -  Adequate hematologic and end-organ function&#xD;
&#xD;
          -  Resolution of any acute, clinically significant treatment-related toxicity from prior&#xD;
             therapy to Grade &lt;= 1 prior to study entry, with the exception of alopecia&#xD;
&#xD;
          -  Negative HIV test at screening with the following exception: patients with a positive&#xD;
             HIV test at screening are eligible provided they are stable on anti-retroviral&#xD;
             therapy, have a CD4 count ≥200µL, and have an undetectable viral load;&#xD;
&#xD;
          -  In patients with viral HCC, documented virology status of hepatitis, as confirmed by&#xD;
             screening HBV and HCV serology test;&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraceptive methods, and agreement to refrain from&#xD;
             donating eggs.&#xD;
&#xD;
          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use&#xD;
             contraceptive measures, and agreement to refrain from donating sperm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of leptomeningeal disease or brain metastases;&#xD;
&#xD;
          -  Active or history of autoimmune disease or immune deficiency;&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced&#xD;
             pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
             chest computed tomography (CT) scan;&#xD;
&#xD;
          -  Known active tuberculosis;&#xD;
&#xD;
          -  Significant cardiovascular disease within 3 months prior to initiation of study&#xD;
             treatment, unstable arrhythmia, or unstable angina;&#xD;
&#xD;
          -  History of malignancy other than HCC within 5 years prior to screening, with the&#xD;
             exception of malignancies with a negligible risk of metastasis or death;&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplantation;&#xD;
&#xD;
          -  Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment&#xD;
             or within at least 5 months after the last dose of atezolizumab and 6 months after the&#xD;
             last dose of bevacizumab;&#xD;
&#xD;
          -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;&#xD;
&#xD;
          -  Untreated or incompletely treated esophageal and/or gastric varices with bleeding or&#xD;
             high-risk for bleeding;&#xD;
&#xD;
          -  A prior bleeding event due to oesophageal and/or gastric varices within 6 months prior&#xD;
             to initiation of study treatment;&#xD;
&#xD;
          -  Clinically evident ascites;&#xD;
&#xD;
          -  Co-infection of HBV and HCV;&#xD;
&#xD;
          -  Co-infection with HBV and hepatitis D viral infection;&#xD;
&#xD;
          -  Symptomatic, untreated, or actively progressing central nervous system (CNS)&#xD;
             metastases;&#xD;
&#xD;
          -  Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
             drainage procedures;&#xD;
&#xD;
          -  Clinically significant uncontrolled or symptomatic hypercalcemia;&#xD;
&#xD;
          -  Inadequately controlled arterial hypertension;&#xD;
&#xD;
          -  Significant vascular disease within 6 months prior to initiation of study treatment;&#xD;
&#xD;
          -  History of haemoptysis;&#xD;
&#xD;
          -  Evidence of bleeding diathesis or significant coagulopathy;&#xD;
&#xD;
          -  History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess&#xD;
             within 6 months prior to initiation of study treatment;&#xD;
&#xD;
          -  History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction&#xD;
             including sub-occlusive disease related to the underlying disease or requirement for&#xD;
             routine parenteral hydration, parenteral nutrition, or tube feeding prior to&#xD;
             initiation of study treatment;&#xD;
&#xD;
          -  Metastatic disease that involves major airways or blood vessels, or centrally located&#xD;
             mediastinal tumor masses of large volume;&#xD;
&#xD;
          -  Local therapy to liver within 28 days prior to initiation of study treatment or&#xD;
             non-recovery from side effects of any such procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Pascale; U.O. Sperimentazioni Cliniche</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale del Mare; UOC di Oncologia</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale Santa Maria Nuova; Oncologia</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Emilia-Romagna</state>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>151</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Universitaria S. Martino Di Genova</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti - Bergamo; Gastroenterologia</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Dei Tumori; Dipartimento Chirurgia Generale - Unita' Trapianti Fegato</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ordine Mauriziano di Torino</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Puglia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia</name>
      <address>
        <city>Cagliari</city>
        <state>Sardegna</state>
        <zip>09100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U Careggi</name>
      <address>
        <city>Florence</city>
        <state>Toscana</state>
        <zip>50124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Oncologica-Ospedali Riuniti Ancona</name>
      <address>
        <city>Torrette</city>
        <state>Toscana</state>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</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>Bevacizumab</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </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/NCT04487067
org study id: ML42243
nct id: NCT04487067
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety
      and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have
      received no prior systemic treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Grade 3-5 NCI CTCAE v.5 Bleeding/Haemorrhage
time frame: Up to approximately 48 months
measure: Overall Survival (OS)
time frame: Up to approximately 48 months
description: Overall survival (OS) is defined as the time from initiation of study treatment to death from any cause.
measure: Number of Participants with Adverse Events
time frame: Up to approximately 48 months
description: Number of participants with adverse events with severity determined according to NCI CTCAE v5.0.
measure: Progression-Free Survival (PFS)
time frame: Up to approximately 48 months
description: Progression-free survival (PFS) is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
measure: Objective Response Rate (ORR)
time frame: Up to approximately 48 months
description: Objective response rate (ORR) is defined as a complete or partial response, as determined by the investigator according to RECIST v1.1
measure: Time to Progression (TTP)
time frame: Up to approximately 48 months
description: Time to progression (TTP) is defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1
measure: Duration of Response (DOR)
time frame: Up to approximately 48 months
description: Duration of response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
measure: Post-Progression Survival (PPS)
time frame: Up to approximately 48 months
description: Post-progression survival (PPS) is defined as the time from the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 to death from any cause.
measure: Number of Participants Starting Second or Further Lines of Treatment
time frame: Up to approximately 48 months
measure: Number of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
time frame: Up to approximately 48 months
description: Participant self-reported symptomatic Adverse Events (AEs) using National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire.
arm group label: Atezolizumab + Bevacizumab
arm group type: Experimental
description: Participants will receive atezolizumab 1200 mg intravenous (IV) infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg IV Q3W (dosed in 3-week cycles)
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab 1200 mg IV infusion q3w
arm group label: Atezolizumab + Bevacizumab
other name: Tecentriq
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab 15 mg/kg IV Q3W
arm group label: Atezolizumab + Bevacizumab
other name: Avastin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Bevacizumab
mesh term: Atezolizumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).