<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/NCT04447274</url>
  </required_header>
  <id_info>
    <org_study_id>UPS and ASPS-IIT-SHR1210</org_study_id>
    <nct_id>NCT04447274</nct_id>
  </id_info>
  <brief_title>A Study of Carilizumab in Combination With Apatinib in Subjects With Unresectable UPS and ASPS</brief_title>
  <official_title>A Single-arm, Open, Prospective, Single-center, Phase Ⅱ Clinical Study of Carilizumab Combined With Apatinib in theTtreatment of Advanced Inoperable Resection of Undifferentiated Pleomorphic Sarcoma and Alveolar Soft Tissue Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Single-arm, Open, Prospective, Single-center, Phase Ⅱ Clinical Study ,Target&#xD;
      population is Advanced Inoperable Resection of Undifferentiated Pleomorphic Sarcoma (UPS) and&#xD;
      Alveolar Soft Tissue Sarcoma (ASPS) .&#xD;
&#xD;
      The purpose of this study was to evaluate the safety and efficacy of combination of&#xD;
      Camrelizumab and Apatinib in the treatment of unresectable UPS and ASPS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, eligible subject to accept study treatment. Camrelizumab combined with&#xD;
      apatinib is a treatment cycle every 2 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free rate at 12 weeks (PFR 12weeks)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The RECIST 1.1 standard was used to evaluate the disease progression and the 12 week progression free rate was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR)</measure>
    <time_frame>6.5 months</time_frame>
    <description>It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival(PFS)</measure>
    <time_frame>6.5 months</time_frame>
    <description>Refers to the date from the beginning of treatment to the first occurrence of disease progression or death caused by any reason, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response（DOR)</measure>
    <time_frame>6.5 months</time_frame>
    <description>Time from the first assessment of Cr or PR to the first assessment of PD or death from any cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Camrelizumab and Apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab and Apatinib</intervention_name>
    <description>Subject will receive SHR-1210 200mg every 2 weeks, with intravenous drip Apatinib 425 mg, oral, 5 consecutive days, 2 days off,each 14 day of a cycles</description>
    <arm_group_label>Camrelizumab and Apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects &gt;/= 16 years of age at the time of Informed Consent,male or female;&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
          3. Life expectancy of at least three months;&#xD;
&#xD;
          4. Advanced undifferentiated pleomorphic sarcoma (UPS) confirmed by histopathology,&#xD;
             patients who have failed in the first-line treatment and have progressed for 6 months;&#xD;
             advanced acinar soft tissue sarcoma (ASPS) confirmed by histopathology, patients who&#xD;
             have not been treated or who have failed in the first-line anti vascular drug&#xD;
             treatment and progressed within 6 months;&#xD;
&#xD;
          5. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard&#xD;
             (the CT scan length of the tumor lesion &gt; 10 mm;&#xD;
&#xD;
          6. All acute toxic reactions caused by previous anti-tumor treatment were relieved to 0-1&#xD;
             level before enrollment (according to NCI CTCAE 5.03) Version) or to the level&#xD;
             specified in the inclusion / exclusion criteria (except for the toxicity that&#xD;
             researchers think does not pose a safety risk to subjects, such as hair loss); if&#xD;
             subjects undergo major surgery, they must have fully recovered from complications&#xD;
             before starting treatment;&#xD;
&#xD;
          7. The main organ function is normal. All baseline laboratory requirements will be&#xD;
             assessed and should be obtained within -14 days of randomization. Screening laboratory&#xD;
             values must meet the following criteria.&#xD;
&#xD;
               1. Hemoglobin ≥ 8.0 g/dL (90 g/L)&#xD;
&#xD;
               2. Absolute neutrophil count ≥ 1.5× 109/L&#xD;
&#xD;
               3. Platelets ≥ 80× 109/L&#xD;
&#xD;
               4. Total bilirubin (TBIL) &lt; 1.5 × upper limit of normal (ULN)&#xD;
&#xD;
               5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) &lt; 2.5 × upper&#xD;
                  limit of normal(ULN);but &lt; 5uln in patients with liver metastasis, alkaline&#xD;
                  phosphatase &lt; 5 × ULN&#xD;
&#xD;
               6. Serum creatinine ≤ 1× ULN or creatinine clearance &gt; 45 mL/minute (using&#xD;
                  Cockcroft/Gault formula);&#xD;
&#xD;
          8. Women of childbearing age must have taken reliable contraceptive measures or carried&#xD;
             out pregnancy test (serum or urine) within 7 days before entering the group, and the&#xD;
             result is negative, and they are willing to use appropriate contraceptive methods&#xD;
             during the test and 60 days after the last administration of test drugs. For men, they&#xD;
             must agree to use appropriate methods of contraception or have undergone surgical&#xD;
             sterilization during the trial period and within 120 days after the last&#xD;
             administration of the trial drug;&#xD;
&#xD;
          9. Subjects should be voluntarily participate in clinical studies and informed consent&#xD;
             should be signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known active central nervous system (CNS) metastasis and / or cancerous meningitis.&#xD;
             Subjects who had previously received brain metastases may participate as long as they&#xD;
             are stable and meet the following criteria: there is no evidence of imaging progress&#xD;
             for at least four weeks prior to the first dose of trial treatment, and any&#xD;
             neurological symptoms have returned to baseline, there is no evidence of new or&#xD;
             expanded brain metastases, and steroids are not used for at least seven days prior to&#xD;
             the trial treatment. This exception does not include cancerous meningitis, regardless&#xD;
             of its clinical stability;&#xD;
&#xD;
          2. Immunosuppressive drugs were used within 14 days before the first use of carrizumab,&#xD;
             excluding nasal spray and inhaled corticosteroids or systemic steroids with&#xD;
             physiological dose (i.e. no more than 10 mg / day of prednisolone or other&#xD;
             corticosteroids with physiological dose of the same drug); 3. Previously received the&#xD;
             following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another&#xD;
             stimulation or synergistic inhibition of T cell receptor (for example, CTLA-4, OX-40,&#xD;
             CD137); 4. Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or&#xD;
             diastolic blood pressure ≥ 90 mmHg, despite systematic medication); 5. Severe&#xD;
             cardiovascular disease: myocardial ischemia or myocardial infarction above grade II,&#xD;
             poor control of arrhythmia (including QTc interval ≥ 450 ms for men and 470 MS for&#xD;
             women); cardiac insufficiency of grade III-IV (according to NYHA classification of New&#xD;
             York Heart Association, see Annex 3), or left ventricular ejection fraction (LVEF) &lt;&#xD;
             50% indicated by color Doppler echocardiography; 6. Patients with any active&#xD;
             autoimmune disease or history of autoimmune disease (including but not limited to:&#xD;
             autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis,&#xD;
             vasculitis, nephritis, hyperthyroidism, hypothyroidism) shall not be included; 7. The&#xD;
             subjects received systematic treatment such as bronchodilator, and the asthma control&#xD;
             was not satisfactory and could not be included (the asthma in childhood has been&#xD;
             completely relieved, and the adult can be included without any intervention); 8.&#xD;
             Routine urine test indicated that urine protein was ≥ 1.0g, or 24-hour urine protein&#xD;
             was ≥ 1.0g; 9. Abnormal coagulation (INR &gt; 1.5 ULN or prothrombin time (PT) &gt; ULN + 4&#xD;
             seconds or APTT &gt; 1.5 ULN), with bleeding tendency or undergoing thrombolysis or&#xD;
             anticoagulation treatment; Note: on the premise that the international standard ratio&#xD;
             of prothrombin time (INR) is less than or equal to 1.5, it is allowed to use low-dose&#xD;
             heparin (6000-12000 u daily for adults) or aspirin (less than or equal to 100 mg&#xD;
             daily) for prevention purposes; 10. Severe infection (such as intravenous drip of&#xD;
             antibiotics, antifungal drugs or antiviral drugs) occurred within 4 weeks before the&#xD;
             first administration, or fever of unknown cause occurred during screening / before the&#xD;
             first administration &gt; 38.5 ° C; 11. Serious arteriovenous thrombotic events occurred&#xD;
             in the first 12 months, such as cerebrovascular accident (including temporary ischemic&#xD;
             attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary&#xD;
             embolism; 12. In the first 4 weeks of the group, they had undergone major surgery or&#xD;
             had severe traumatic injury, fracture or ulcer; 13. Human immunodeficiency virus (HIV)&#xD;
             infection or known acquired immunodeficiency syndrome (AIDS), active tuberculosis,&#xD;
             active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and&#xD;
             HCV-RNA higher than the detection limit of the analysis method) or co infection with&#xD;
             hepatitis B and C; 14. Patients with a clear history of allergy may be potentially&#xD;
             allergic or intolerant to the biological agents of apatinib and carrizumab; 15. There&#xD;
             are obvious factors affecting the absorption of oral drugs, such as inability to&#xD;
             swallow, chronic diarrhea and intestinal obstruction. Or there were cavity organ sinus&#xD;
             or perforation within 6 months; 16. Those who have a history of abuse of psychotropic&#xD;
             substances and are unable to give up or have mental disorders; 17. Increase the risk&#xD;
             associated with participating in the study or study drug, and other circumstances&#xD;
             that, in the judgment of the investigator, may result in the patient not being&#xD;
             eligible for inclusion in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yihebali Chi, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yihebali Chi, doctor</last_name>
    <phone>13911075626</phone>
    <email>yihebalichi6@126.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>yihebali chi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Camrelizumab</keyword>
  <keyword>Apatinib</keyword>
  <keyword>UPS</keyword>
  <keyword>ASPS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</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/NCT04447274
org study id: UPS and ASPS-IIT-SHR1210
nct id: NCT04447274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a Single-arm, Open, Prospective, Single-center, Phase Ⅱ Clinical Study ,Target
      population is Advanced Inoperable Resection of Undifferentiated Pleomorphic Sarcoma (UPS) and
      Alveolar Soft Tissue Sarcoma (ASPS) .

      The purpose of this study was to evaluate the safety and efficacy of combination of
      Camrelizumab and Apatinib in the treatment of unresectable UPS and ASPS
In this study, eligible subject to accept study treatment. Camrelizumab combined with
      apatinib is a treatment cycle every 2 weeks
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free rate at 12 weeks (PFR 12weeks)
time frame: 12 weeks
description: The RECIST 1.1 standard was used to evaluate the disease progression and the 12 week progression free rate was calculated.
measure: Objective Response Rate(ORR)
time frame: 6.5 months
description: It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR
measure: Progression free survival(PFS)
time frame: 6.5 months
description: Refers to the date from the beginning of treatment to the first occurrence of disease progression or death caused by any reason, whichever occurs first
measure: Duration of Response（DOR)
time frame: 6.5 months
description: Time from the first assessment of Cr or PR to the first assessment of PD or death from any cause
arm group label: Camrelizumab and Apatinib
arm group type: Experimental
description: Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
intervention type: Drug
intervention name: Camrelizumab and Apatinib
description: Subject will receive SHR-1210 200mg every 2 weeks, with intravenous drip Apatinib 425 mg, oral, 5 consecutive days, 2 days off,each 14 day of a cycles
arm group label: Camrelizumab and Apatinib
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Yihebali Chi, doctor
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Yihebali Chi, doctor
phone: 13911075626
email: yihebalichi6@126.com
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: yihebali chi
investigator title: Assistant Professor
mesh term: Sarcoma
mesh term: Apatinib