<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/NCT03812874</url>
  </required_header>
  <id_info>
    <org_study_id>PTX-9908-HCC-01</org_study_id>
    <nct_id>NCT03812874</nct_id>
  </id_info>
  <brief_title>A Study of PTX-9908 Injection for Non-resectable HCC With TACE</brief_title>
  <official_title>Phase I/II Study of PTX-9908 Injection as an Inhibitor of Cancer Progression in Patients With Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TCM Biotech International Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TCM Biotech International Corp.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular&#xD;
      carcinoma following TACE treatment.&#xD;
&#xD;
      Phase I (Open-label dose escalation)&#xD;
&#xD;
      This study will be an open-label study with an Accelerated Phase and a Standard Phase. For&#xD;
      the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is&#xD;
      planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will&#xD;
      follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE&#xD;
      treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose&#xD;
      per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week&#xD;
      (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be&#xD;
      followed by a 2-week follow-up period.&#xD;
&#xD;
      Phase II (Randomized placebo controlled dose expansion)&#xD;
&#xD;
      The objective of phase II is to further evaluate the safety, tolerability and antitumor&#xD;
      activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma&#xD;
      following TACE treatment. Approximately 24 eligible patients who have received TACE treatment&#xD;
      and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase&#xD;
      I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered&#xD;
      intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays),&#xD;
      and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed&#xD;
      by a 2-week follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2024</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Phase I: Singe-arm, open-labeled Phase II: Randomized, placebo-controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>For Phase II only.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as measured by the number and severity of Adverse Events</measure>
    <time_frame>Week 1 - Week 8 (Phase I)/Week 16 (Phase II)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as measured by number of participants with a dose limiting toxicity (DLT)</measure>
    <time_frame>Week 1 - Week 6 (Phase I only)</time_frame>
    <description>Any of the following, if judged to be associated with PTX-9908 Injection or the combination of TACE with PTX-9908 Injection (i.e., with possible causality) that occur within the DLT evaluation window, will be considered as a DLT.&#xD;
All Grade 4 (i.e., life-threatening) non-hematological and hematological toxicities (except for Grade 4 lymphopenia).&#xD;
Grade 3 anemia with clinically significant bleeding&#xD;
All grades of febrile neutropenia.&#xD;
All Grade 3 non-laboratory/non-hematologic treatment-emergent adverse events, with the exception for nausea, vomiting, or diarrhea that resolves within 3 days.&#xD;
Grade 3 thrombocytopenia with clinically significant bleeding is a DLT.&#xD;
Grade 3 cytokine release syndrome of any duration is a DLT.&#xD;
Grade 3 laboratory adverse events that are judged by the investigator as clinically significant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recommended Phase 2 Dose (RP2D)</measure>
    <time_frame>Week 1 - Week 6 (Phase I only)</time_frame>
    <description>The RP2D was based on the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level, and the assessment of any relevant chronic toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of single-dose and repeat-dose of PTX-9908 Injection</measure>
    <time_frame>Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II</time_frame>
    <description>Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of PTX-9908 Injection administered with IV dose derived from plasma concentration versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (T-Half) of single-dose and repeat-dose of PTX-9908 Injection</measure>
    <time_frame>Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II</time_frame>
    <description>PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of PTX-9908 Injection administered with IV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Tumor Response</measure>
    <time_frame>Week 1 - Week 16 (Phase II)</time_frame>
    <description>Number of participants with a best overall tumor response of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Overall tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response of target hepatic lesions in embolized territory</measure>
    <time_frame>Week 1 - Week 16 (Phase II)</time_frame>
    <description>Number of participants with hepatic lesion in embolized territory of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate overall time-to-progression</measure>
    <time_frame>Week 1 - Week 16 (Phase II)</time_frame>
    <description>Time to progression (TPP) will start from TACE administration to radiological progression. Definition of progression is based on the mRECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate change in AFP levels.</measure>
    <time_frame>Week 1 - Week 16 (Phase II)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>PTX-9908 Injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/Vehicle group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IV injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PTX-9908 Injection</intervention_name>
    <description>Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.&#xD;
Frequency:&#xD;
Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).&#xD;
Duration: 4 weeks (Phase I) and 12 weeks (Phase II).</description>
    <arm_group_label>PTX-9908 Injection group</arm_group_label>
    <arm_group_label>Placebo/Vehicle group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>water for injection&#xD;
Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).&#xD;
Duration: 12 weeks (Phase II)</description>
    <arm_group_label>Placebo/Vehicle group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or&#xD;
             Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or&#xD;
             extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study&#xD;
             intervention infusion.&#xD;
&#xD;
          2. Recovered from TACE treatment and procedure related toxicities including ALT/AST and&#xD;
             bilirubin within normal limit or reference numeric value (reference value is defined&#xD;
             as the test value before TACE procedure).&#xD;
&#xD;
          3. ECOG (Eastern Cooperative Oncology Group) performance status &lt; 2.&#xD;
&#xD;
          4. Have adequate organ and marrow function as defined below:&#xD;
&#xD;
               1. Absolute neutrophil count &gt; 1,200/µL&#xD;
&#xD;
               2. Hemoglobin &gt; 9 g/dL&#xD;
&#xD;
               3. Platelets &gt; 100,000/µL&#xD;
&#xD;
               4. Total bilirubin &lt; 2 X ULN&#xD;
&#xD;
          5. Have adequate kidney function as estimated glomerular filtration rate (eGFR) &gt; 60&#xD;
             mL/min/1.73m2&#xD;
&#xD;
          6. A negative pregnancy test at screening. This applies to any female patient with&#xD;
             childbearing potential.&#xD;
&#xD;
          7. Agree to use adequate contraception after signing informed consent form, during the&#xD;
             duration of study participation and for at least 4-weeks after completion or&#xD;
             withdrawal from the study. This applies to any female patient with childbearing&#xD;
             potential and any male patient whose female partner has childbearing potential.&#xD;
&#xD;
             Acceptable contraceptive methods include:&#xD;
&#xD;
               1. Established use of oral, injected or implanted hormonal methods of contraception&#xD;
&#xD;
               2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)&#xD;
&#xD;
               3. Barrier methods of contraception: condom or occlusive cap (diaphragm or&#xD;
                  cervical/vault caps) &gt;=20 years of age. (Note: In Taiwan, age of majority&#xD;
                  recognized in law is 20 years of age)&#xD;
&#xD;
          8. &gt;=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of&#xD;
             age)&#xD;
&#xD;
          9. Anticipated life expectancy of &gt;= 6 months at assessment during screening.&#xD;
&#xD;
         10. Ability to understand and have signed a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 1. Patient with Child-Pugh B8-9.&#xD;
&#xD;
          2. Patient who has had anti-cancer therapy including surgery, radiotherapy,&#xD;
             immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the&#xD;
             screening visit.&#xD;
&#xD;
          3. Patient who has received any other investigational agents within 4 weeks prior to the&#xD;
             screening visit.&#xD;
&#xD;
          4. Patient who has not recovered from the side effects of the earlier investigational&#xD;
             agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or&#xD;
             chemotherapy.&#xD;
&#xD;
          5. Patient with known brain metastases, leptomeningeal or epidural metastases (unless&#xD;
             treated and well controlled for &gt;= 3 months).&#xD;
&#xD;
          6. Patient with prior history of co-malignancies, except for adequately treated carcinoma&#xD;
             in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal&#xD;
             cell/squamous cell skin cancer.&#xD;
&#xD;
          7. Patient with history of myocardial infarction or uncontrolled cardiac dysfunction, or&#xD;
             unstable arrhythmia or symptomatic peripheral arterial vascular disease.&#xD;
&#xD;
          8. Patient with history of positive serology for human immunodeficiency virus (HIV).&#xD;
&#xD;
          9. Patient with active, uncontrolled bacterial, viral, or fungal infections, which&#xD;
             require systemic therapy.&#xD;
&#xD;
         10. Patient with poor liver function as indicated by serum bilirubin &gt; 2 mg/dL, Child-Pugh&#xD;
             Class C, severe coagulopathy (INR &gt; 2) not correctable with vitamin K, or active&#xD;
             hepatic encephalopathy.&#xD;
&#xD;
         11. Patient with known allergic reactions to biological agent or polypeptides similar to&#xD;
             PTX-9908 Injection.&#xD;
&#xD;
         12. Woman who is pregnant or nursing.&#xD;
&#xD;
         13. Patient with concomitant disease or condition that could interfere with the conduct of&#xD;
             the study, or that would, in the opinion of the investigator, pose an unacceptable&#xD;
             risk to the patient in this study.&#xD;
&#xD;
         14. Patient with unwillingness or inability to comply with the study protocol for any&#xD;
             reason.&#xD;
&#xD;
         15. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction&#xD;
             formula&#xD;
&#xD;
         16. A history of additional risk factors for torsades de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
         17. The use of concomitant medications that prolong the QT/QTc interval&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Hung Chien-Hung, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chien-Hung Chen, MD, PhD</last_name>
    <phone>+886 2312 3456</phone>
    <phone_ext>65923</phone_ext>
    <email>chenhcc@ntuh.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chien-Hung Chen, MD, PhD</last_name>
      <phone>+886 2312 3456</phone>
      <phone_ext>65923</phone_ext>
      <email>chenhcc@ntuh.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>June 25, 2023</last_update_submitted>
  <last_update_submitted_qc>June 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03812874
org study id: PTX-9908-HCC-01
nct id: NCT03812874
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular
      carcinoma following TACE treatment.

      Phase I (Open-label dose escalation)

      This study will be an open-label study with an Accelerated Phase and a Standard Phase. For
      the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is
      planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will
      follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE
      treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose
      per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week
      (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be
      followed by a 2-week follow-up period.

      Phase II (Randomized placebo controlled dose expansion)

      The objective of phase II is to further evaluate the safety, tolerability and antitumor
      activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma
      following TACE treatment. Approximately 24 eligible patients who have received TACE treatment
      and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase
      I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered
      intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays),
      and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed
      by a 2-week follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase I: Singe-arm, open-labeled Phase II: Randomized, placebo-controlled
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: For Phase II only.
measure: Safety as measured by the number and severity of Adverse Events
time frame: Week 1 - Week 8 (Phase I)/Week 16 (Phase II)
measure: Safety as measured by number of participants with a dose limiting toxicity (DLT)
time frame: Week 1 - Week 6 (Phase I only)
description: Any of the following, if judged to be associated with PTX-9908 Injection or the combination of TACE with PTX-9908 Injection (i.e., with possible causality) that occur within the DLT evaluation window, will be considered as a DLT.
All Grade 4 (i.e., life-threatening) non-hematological and hematological toxicities (except for Grade 4 lymphopenia).
Grade 3 anemia with clinically significant bleeding
All grades of febrile neutropenia.
All Grade 3 non-laboratory/non-hematologic treatment-emergent adverse events, with the exception for nausea, vomiting, or diarrhea that resolves within 3 days.
Grade 3 thrombocytopenia with clinically significant bleeding is a DLT.
Grade 3 cytokine release syndrome of any duration is a DLT.
Grade 3 laboratory adverse events that are judged by the investigator as clinically significant.
measure: Recommended Phase 2 Dose (RP2D)
time frame: Week 1 - Week 6 (Phase I only)
description: The RP2D was based on the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level, and the assessment of any relevant chronic toxicity.
measure: Maximum Plasma Concentration (Cmax) of single-dose and repeat-dose of PTX-9908 Injection
time frame: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
description: Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of PTX-9908 Injection administered with IV dose derived from plasma concentration versus time data.
measure: Terminal Half-life (T-Half) of single-dose and repeat-dose of PTX-9908 Injection
time frame: Day 1, Day 5, Day 8, Day 15, and Day 26 in Phase I and Phase II
description: PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of PTX-9908 Injection administered with IV.
measure: Overall Tumor Response
time frame: Week 1 - Week 16 (Phase II)
description: Number of participants with a best overall tumor response of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Overall tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST.
measure: Response of target hepatic lesions in embolized territory
time frame: Week 1 - Week 16 (Phase II)
description: Number of participants with hepatic lesion in embolized territory of complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Tumor response will be assessed using contrast-enhanced CT imaging according to mRECIST criteria following the 1.1 release of RECIST
measure: To evaluate overall time-to-progression
time frame: Week 1 - Week 16 (Phase II)
description: Time to progression (TPP) will start from TACE administration to radiological progression. Definition of progression is based on the mRECIST criteria.
measure: To evaluate change in AFP levels.
time frame: Week 1 - Week 16 (Phase II)
arm group label: PTX-9908 Injection group
arm group type: Experimental
description: IV injection.
arm group label: Placebo/Vehicle group
arm group type: Placebo Comparator
description: IV injection
intervention type: Drug
intervention name: PTX-9908 Injection
description: Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.
Frequency:
Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
Duration: 4 weeks (Phase I) and 12 weeks (Phase II).
arm group label: PTX-9908 Injection group
arm group label: Placebo/Vehicle group
intervention type: Drug
intervention name: Placebo
description: water for injection
Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
Duration: 12 weeks (Phase II)
arm group label: Placebo/Vehicle group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chien-Hung Chien-Hung, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chien-Hung Chen, MD, PhD
phone: +886 2312 3456
phone ext: 65923
email: chenhcc@ntuh.gov.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided