<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/NCT04443036</url>
  </required_header>
  <id_info>
    <org_study_id>GC-ATJogress</org_study_id>
    <nct_id>NCT04443036</nct_id>
  </id_info>
  <brief_title>Clinical Study of Nab-paclitaxel Combined With Toripalimab in Local Advanced or Metastatic G/GEJ Carcinoma</brief_title>
  <official_title>Albumin-bound Paclitaxel Combined With Toripalimab as First-line/Second-line Treatment of Local Advanced or Metastatic Gastric or Gastroesophageal Junction Carcinoma: A Prospective, Open-label, Single-arm Phase II Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy and safety of Albumin-bound paclitaxel combined with&#xD;
      Toripalimab as first-line/second-line treatment of local advanced or metastatic gastric or&#xD;
      gastroesophageal junction carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <phase>N/A</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>PFS</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Progression-Free Survival&#xD;
Defined as the time from first dose of study medication to the first documented disease progression per RECIST version 1.1，or death from any cause, whichever occurred first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Objective Response Rate&#xD;
Defined as the proportion of patients with confirmed complete response /partial response per RECIST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Disease control rate&#xD;
Defined as the proportion of patients with confirmed complete response /partial response/ Stable Disease per RECIST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Over survival&#xD;
Defined as the time from the date of first dose of study medication to the date of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life(QoL)：measured by EORTC QLQ-C30 questionnaire</measure>
    <time_frame>up to 24 months</time_frame>
    <description>European Organisation for Research and Treatment of Cancer's Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)&#xD;
The change in the quality of life as measured by EORTC QLQ-C30, consists of 30 questions that provide a global QoL scale, five functional scales (physical, role-playing, emotional, cognitive, social), three symptom scales (fatigue, nausea and vomiting, pain) and six individual factors (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). The scores of each scale are calculated in a score ranging from 0 to 100. A high score on a functional scale represents a good level of function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 24 months</time_frame>
    <description>- Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Gastric Carcinoma</condition>
  <arm_group>
    <arm_group_label>Albumin-bound Paclitaxel Combined With Toripalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albumin-bound Paclitaxel：125mg/m2 IV d1、8，Q3W&#xD;
Toripalimab：240 mg，IV d1，Q3W&#xD;
until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration of Toripalimab is 24 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin-Bound Paclitaxel</intervention_name>
    <description>125mg/m2 IV d1、8，Q3W&#xD;
until disease progression, lost follow-up visit, death , unacceptable toxicity</description>
    <arm_group_label>Albumin-bound Paclitaxel Combined With Toripalimab</arm_group_label>
    <other_name>Paclitaxel (albumin-bound)</other_name>
    <other_name>Paclitaxel for injection(Albumin Bound)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toripalimab</intervention_name>
    <description>240 mg，IV d1，Q3W&#xD;
until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months</description>
    <arm_group_label>Albumin-bound Paclitaxel Combined With Toripalimab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:18-70 years old, female or male.&#xD;
&#xD;
          -  Histopathologically diagnosed local advanced or metastatic gastric or gastroesophageal&#xD;
             junction carcinoma, HER2 negative.&#xD;
&#xD;
          -  At least one measurable lesion according to RECIST 1.1.&#xD;
&#xD;
          -  ≤1 prior line. adjuvant/neoadjuvant therapy is allowed, adjuvant/neoadjuvant therapy&#xD;
             is considered as the first-line treatment for advanced diseases, if recurrence occurs&#xD;
             during the treatment or within 6 months after the last treatment. prior chemotherapy&#xD;
             combined with targeted therapy is allowed.&#xD;
&#xD;
          -  ECOG performance status of 0 or 1.&#xD;
&#xD;
          -  Adequate organ and bone marrow function: ANC≥1.5×109/L, PLT≥90×109/L,&#xD;
             HGB≥90g/L,TBil≤1.5ULN, ALT≤2.5ULN, AST≤2.5ULN, Serum Cr≤1ULN, endogenous creatinine&#xD;
             clearance&gt;60ml/min (Cockcroft-Gault formula).&#xD;
&#xD;
          -  The international normalized ratio (INR) ≤ 1.5 and some prothrombin time (PPT or APTT)&#xD;
             ≤ 1.5ULN within 7 days before enrollment.&#xD;
&#xD;
          -  Expected survival≥3 months.&#xD;
&#xD;
          -  Signed informed consent (ICF) before enrollment.&#xD;
&#xD;
          -  Women of childbearing age must undergo a pregnancy test within 7 days prior to&#xD;
             enrollment and have a negative result and are willing to use effective and reliable&#xD;
             contraceptive methods during and 6 months after the last treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe allergic reactions to chimeric or humanized antibodies or fusion&#xD;
             proteins, or known allergic to any component of Toripalimab or any component of&#xD;
             Albumin Bound paclitaxel.&#xD;
&#xD;
          -  severe hypersensitivity after previous administration of monoclonal antibody.&#xD;
&#xD;
          -  ≥1 prior line therapy after progression.&#xD;
&#xD;
          -  Prior therapy with PD-1、PD-L1/L2、CTLA-4 antibody, or any other immunotherapy.&#xD;
&#xD;
          -  A history of organ transplantation.&#xD;
&#xD;
          -  Any other malignancy within 5 years excluding healed Basal cell carcinoma or squamous&#xD;
             cell carcinoma of the skin or carcinoma in situ of cervical or breast.&#xD;
&#xD;
          -  Received anti-tumor vaccine or other immune-stimulating agents (interferon,&#xD;
             interleukin, thymosin, immuno cell therapy, etc.) within 1 month before the first&#xD;
             treatment.&#xD;
&#xD;
          -  Symptomatic central nervous system metastases.&#xD;
&#xD;
          -  Acute or chronic Active hepatitis B or hepatitis C.&#xD;
&#xD;
          -  Interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, pulmonary fibrosis,&#xD;
             severely impaired lung function and other pulmonary diseases.&#xD;
&#xD;
          -  Active tuberculosis, receiving anti-TB treatment or have received anti-TB treatment&#xD;
             within 1 year prior to first treatment.&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection（HIV antibody positive）, or known syphilis&#xD;
             infection.&#xD;
&#xD;
          -  Severe uncontrolled disease, non-metastatic systemic disease, active or poor clinical&#xD;
             control infection.&#xD;
&#xD;
          -  Patients with autoimmune diseases or abnormal immune system.&#xD;
&#xD;
          -  Treatment with immunosuppressive medications within 4 weeks prior to enrollment. Nasal&#xD;
             spray, inhalation, or other ways of topical corticosteroids or systemic&#xD;
             corticosteroids at physiologic doses （not to exceed 10 mg/day of prednisone or its&#xD;
             equivalent Steroids）are not included.&#xD;
&#xD;
          -  Expected to require any other form of antitumor therapy while on study (including&#xD;
             maintenance therapy with any other drugs for gastric or gastroesophageal junction&#xD;
             carcinoma、radiotherapy and/or surgical resection)&#xD;
&#xD;
          -  Received major surgery or radiation therapy of &gt; 30 Gy not to chest within 4 weeks of&#xD;
             the first treatment, or radiation therapy of &gt; 30 Gy to chest within 24 weeks of the&#xD;
             first treatment,or radiation therapy of &lt; 30 Gy to chest within 2 weeks of the first&#xD;
             treatment, and had not recovered from the toxicity and/or complications of the most&#xD;
             recent prior chemotherapy to Grade 1 or less (except alopecia or fatigue).&#xD;
&#xD;
          -  Poorly Controlled Diabetes（fasting blood-glucose ≥CTCAE grade 2）.&#xD;
&#xD;
          -  Clinically significant thyroid dysfunction and can't maintain thyroid hormone levels&#xD;
             in the normal range with drugs.&#xD;
&#xD;
          -  Use of any live vaccines within 4 weeks before enrollment.&#xD;
&#xD;
          -  Pregnant or lactating subjects.&#xD;
&#xD;
          -  Participated in any other drug clinical study within 4 weeks before the enrollment.&#xD;
&#xD;
          -  Any other disease、metabolic disorders、Physical examination or laboratory abnormalities&#xD;
             that might result in contraindications in the use of experimental drugs or affect the&#xD;
             reliability of the study, or Puts patients at high risk.&#xD;
&#xD;
          -  The investigator believes are not suitable for participating in the study.&#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_official>
    <last_name>Yunpeng Liu, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Hospital of China Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yunpeng Liu, PhD.</last_name>
    <phone>86-24-83282312</phone>
    <email>cmuliuyunpeng@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiujuan Qu, PhD.</last_name>
    <phone>86-24-83282542</phone>
    <email>qu_xiujuan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunpeng Liu, PhD.</last_name>
      <phone>86-24-83282312</phone>
      <email>cmuliuyunpeng@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Xiujuan Qu, PhD.</last_name>
      <phone>86-24-83282542</phone>
      <email>qu_xiujuan@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Yunpeng Liu</investigator_full_name>
    <investigator_title>Director of Department of Medical Oncology</investigator_title>
  </responsible_party>
  <keyword>gastric carcinoma</keyword>
  <keyword>gastroesophageal junction carcinoma</keyword>
  <keyword>Albumin Bound Paclitaxel</keyword>
  <keyword>Toripalimab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04443036
org study id: GC-ATJogress
nct id: NCT04443036
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the efficacy and safety of Albumin-bound paclitaxel combined with
      Toripalimab as first-line/second-line treatment of local advanced or metastatic gastric or
      gastroesophageal junction carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: up to 24 months
description: Progression-Free Survival
Defined as the time from first dose of study medication to the first documented disease progression per RECIST version 1.1，or death from any cause, whichever occurred first
measure: ORR
time frame: up to 24 months
description: Objective Response Rate
Defined as the proportion of patients with confirmed complete response /partial response per RECIST version 1.1
measure: DCR
time frame: up to 24 months
description: Disease control rate
Defined as the proportion of patients with confirmed complete response /partial response/ Stable Disease per RECIST version 1.1
measure: OS
time frame: up to 24 months
description: Over survival
Defined as the time from the date of first dose of study medication to the date of death from any cause
measure: Change in Quality of Life(QoL)：measured by EORTC QLQ-C30 questionnaire
time frame: up to 24 months
description: European Organisation for Research and Treatment of Cancer's Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The change in the quality of life as measured by EORTC QLQ-C30, consists of 30 questions that provide a global QoL scale, five functional scales (physical, role-playing, emotional, cognitive, social), three symptom scales (fatigue, nausea and vomiting, pain) and six individual factors (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). The scores of each scale are calculated in a score ranging from 0 to 100. A high score on a functional scale represents a good level of function.
measure: Adverse events
time frame: up to 24 months
description: - Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
arm group label: Albumin-bound Paclitaxel Combined With Toripalimab
arm group type: Experimental
description: Albumin-bound Paclitaxel：125mg/m2 IV d1、8，Q3W
Toripalimab：240 mg，IV d1，Q3W
until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration of Toripalimab is 24 months
intervention type: Drug
intervention name: Albumin-Bound Paclitaxel
description: 125mg/m2 IV d1、8，Q3W
until disease progression, lost follow-up visit, death , unacceptable toxicity
arm group label: Albumin-bound Paclitaxel Combined With Toripalimab
other name: Paclitaxel (albumin-bound)
other name: Paclitaxel for injection(Albumin Bound)
intervention type: Drug
intervention name: Toripalimab
description: 240 mg，IV d1，Q3W
until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months
arm group label: Albumin-bound Paclitaxel Combined With Toripalimab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yunpeng Liu, PhD.
role: Principal Investigator
affiliation: First Hospital of China Medical University
last name: Yunpeng Liu, PhD.
phone: 86-24-83282312
email: cmuliuyunpeng@hotmail.com
last name: Xiujuan Qu, PhD.
phone: 86-24-83282542
email: qu_xiujuan@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Yunpeng Liu
investigator title: Director of Department of Medical Oncology
mesh term: Carcinoma
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel