<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/NCT02976740</url>
  </required_header>
  <id_info>
    <org_study_id>KYZ2016-006</org_study_id>
    <nct_id>NCT02976740</nct_id>
  </id_info>
  <brief_title>SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy</brief_title>
  <official_title>A Prospective Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT Combination With rhGM-CSF and Thymosin Alpha 1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Xiamen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)&#xD;
      combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and&#xD;
      Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in&#xD;
      second-line chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to&#xD;
      day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony&#xD;
      stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle.&#xD;
      Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a&#xD;
      consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist&#xD;
      week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be&#xD;
      conducted at the end of therapy and every month after that. Adverse events will be recorded&#xD;
      according to NCI-CTC version 4.03.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>abscopal effect rate</measure>
    <time_frame>at the time point of 4 weeks after completion of the combined treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>1 year after completion of the combined treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse events</measure>
    <time_frame>1 year after completion of the combined treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective response rate</measure>
    <time_frame>4 weeks after completion of the combined treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of immune-related adverse events</measure>
    <time_frame>1 year after completion of the combined treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Lung Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>SBRT+GM-CSF+Tα1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metastasis lesion will be treated with a SBRT of 50Gy/4-10F from day 1 to day 10 . Subcutaneous injection of Immunological Agent- human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Subcutaneous injection of another Immunological Factors Thymosin Alpha 1(1.6mg Biw)will be executed from the fist WEEK to the 12th Weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT</intervention_name>
    <description>Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion</description>
    <arm_group_label>SBRT+GM-CSF+Tα1</arm_group_label>
    <other_name>SABR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunological Agent</intervention_name>
    <description>Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.</description>
    <arm_group_label>SBRT+GM-CSF+Tα1</arm_group_label>
    <other_name>rh GM-CSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunological Factors</intervention_name>
    <description>Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.</description>
    <arm_group_label>SBRT+GM-CSF+Tα1</arm_group_label>
    <other_name>Tα1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven non-small-cell lung cancer.&#xD;
&#xD;
          2. Stage IV according to UICC stage system(version 7,2009).&#xD;
&#xD;
          3. Progression after standard second-line chemotherapy.&#xD;
&#xD;
          4. At least Three evaluable lesions among which at least two must be suitable for SBRT.&#xD;
&#xD;
          5. ECOG performance status 0-2.&#xD;
&#xD;
          6. Expected lifespan ≥3 months.&#xD;
&#xD;
          7. Stable lab values:&#xD;
&#xD;
             Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L,&#xD;
             Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance&#xD;
             (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or&#xD;
             CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine&#xD;
             levels &gt;1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin&#xD;
             ≤ULN for patients with total bilirubin levels &gt;1.5×ULN, Aspartate aminotransferase&#xD;
             (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver&#xD;
             metastases ,globulin≥20 g/L, albumin≥30 g/L.&#xD;
&#xD;
          8. Female subjects must have a negative urine or serum pregnancy test within 72 hours&#xD;
             prior to taking study drug if of childbearing potential.&#xD;
&#xD;
          9. Able to understand and give written informed consent and comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any unstable systemic disease, including active infection, uncontrolled high blood&#xD;
             pressure, unstable angina, newly observed angina pectoris within the past 3 months,&#xD;
             congestive heart failure (New York heart association (NYHA) class II or higher),&#xD;
             myocardial infarction onset six months before included into the group, and severe&#xD;
             arrhythmia, liver, kidney, or metabolic disease in need of drug therapy, Including&#xD;
             diabetes.&#xD;
&#xD;
          2. Any clinical evidence suggests moderately severe chronic obstructive pulmonary disease&#xD;
             (COPD) - [With COPD history or related risk factors, FEV1 / FVC &lt; 70%, FEV1 &lt; 80%&#xD;
             estimated value, with or without chronic cough, sputum, dyspnea symptoms), active&#xD;
             interstitial lung disease - ILD (FEV1 / FVC &lt; 70%, FEV1 &lt; 80% estimated value, carbon&#xD;
             monoxide diffusion capacity in lung - DLCO &lt; 40%, and high resolution CT (HRCT)&#xD;
             confirmed as the diffuse pulmonary interstitial lesions] and other active pulmonary&#xD;
             disease.&#xD;
&#xD;
          3. Previously diagnosed with autoimmune diseases, including but not limited to systemic&#xD;
             lupus erythematous, rheumatoid arthritis, systemic vasculitis, scleroderma,&#xD;
             dermatomyositis, autoimmune hemolytic anemia and autoimmune liver disease, autoimmune&#xD;
             thyroiditis.&#xD;
&#xD;
          4. Human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          5. Women in pregnancy or lactation .&#xD;
&#xD;
          6. Medicine abusers(including alcohol, drugs or other addictive drugs abusers).&#xD;
&#xD;
          7. Patients with mental illness, considered as &quot;can't fully understand the issues of this&#xD;
             research&quot;.&#xD;
&#xD;
          8. Cancer history within 5 years apart from NSCLC before enrollment.&#xD;
&#xD;
          9. Histologically confirmed small cell carcinoma or other non NSCLC compositions in the&#xD;
             cancer tissue.&#xD;
&#xD;
         10. Cancer treatment within 4 weeks, including but not limited to palliative surgery&#xD;
             ,radiotherapy, chemotherapy and target therapy.&#xD;
&#xD;
         11. Tumor related immunotherapy within 1 year, including but not limited to immune cell&#xD;
             therapy, tumor vaccine therapy, immune check-point monoclonal antibody related&#xD;
             treatment, and cytokines treatment except for GM-CSF.&#xD;
&#xD;
         12. Allergy of rhGM-CSF/Tα1 and its accessories.&#xD;
&#xD;
         13. Contraindications to GM-CSF/Tα1 treatment.&#xD;
&#xD;
         14. Patients with unilateral lung.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Deng Chong, MD</last_name>
    <phone>86-05922139531</phone>
    <email>dengchongxm@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lin Qin, MD/PhD</last_name>
    <phone>86-05922139531</phone>
    <email>linqin03@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deng Chong, MD</last_name>
      <phone>8605922139531</phone>
      <email>dengchongxm@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Lin Qin, MD/PhD</last_name>
      <phone>8605922139531</phone>
      <email>linqin06@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Deng Chong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lin Qin, MD/PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ye Feng, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>An Hanxiang, MD/PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Liu Qun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Twyman-Saint Victor C, Rech AJ, Maity A, Rengan R, Pauken KE, Stelekati E, Benci JL, Xu B, Dada H, Odorizzi PM, Herati RS, Mansfield KD, Patsch D, Amaravadi RK, Schuchter LM, Ishwaran H, Mick R, Pryma DA, Xu X, Feldman MD, Gangadhar TC, Hahn SM, Wherry EJ, Vonderheide RH, Minn AJ. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015 Apr 16;520(7547):373-7. doi: 10.1038/nature14292. Epub 2015 Mar 9.</citation>
    <PMID>25754329</PMID>
  </reference>
  <reference>
    <citation>Formenti SC, Demaria S. Systemic effects of local radiotherapy. Lancet Oncol. 2009 Jul;10(7):718-26. doi: 10.1016/S1470-2045(09)70082-8.</citation>
    <PMID>19573801</PMID>
  </reference>
  <reference>
    <citation>Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature. 2011 Dec 21;480(7378):480-9. doi: 10.1038/nature10673.</citation>
    <PMID>22193102</PMID>
  </reference>
  <reference>
    <citation>Zeng J, See AP, Phallen J, Jackson CM, Belcaid Z, Ruzevick J, Durham N, Meyer C, Harris TJ, Albesiano E, Pradilla G, Ford E, Wong J, Hammers HJ, Mathios D, Tyler B, Brem H, Tran PT, Pardoll D, Drake CG, Lim M. Anti-PD-1 blockade and stereotactic radiation produce long-term survival in mice with intracranial gliomas. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):343-9. doi: 10.1016/j.ijrobp.2012.12.025. Epub 2013 Feb 22.</citation>
    <PMID>23462419</PMID>
  </reference>
  <reference>
    <citation>Kalbasi A, June CH, Haas N, Vapiwala N. Radiation and immunotherapy: a synergistic combination. J Clin Invest. 2013 Jul;123(7):2756-63. doi: 10.1172/JCI69219. Epub 2013 Jul 1.</citation>
    <PMID>23863633</PMID>
  </reference>
  <reference>
    <citation>Suzuki Y, Mimura K, Yoshimoto Y, Watanabe M, Ohkubo Y, Izawa S, Murata K, Fujii H, Nakano T, Kono K. Immunogenic tumor cell death induced by chemoradiotherapy in patients with esophageal squamous cell carcinoma. Cancer Res. 2012 Aug 15;72(16):3967-76. doi: 10.1158/0008-5472.CAN-12-0851. Epub 2012 Jun 14.</citation>
    <PMID>22700877</PMID>
  </reference>
  <reference>
    <citation>Reits EA, Hodge JW, Herberts CA, Groothuis TA, Chakraborty M, Wansley EK, Camphausen K, Luiten RM, de Ru AH, Neijssen J, Griekspoor A, Mesman E, Verreck FA, Spits H, Schlom J, van Veelen P, Neefjes JJ. Radiation modulates the peptide repertoire, enhances MHC class I expression, and induces successful antitumor immunotherapy. J Exp Med. 2006 May 15;203(5):1259-71. doi: 10.1084/jem.20052494. Epub 2006 Apr 24.</citation>
    <PMID>16636135</PMID>
  </reference>
  <reference>
    <citation>Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824.</citation>
    <PMID>22397654</PMID>
  </reference>
  <results_reference>
    <citation>Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.</citation>
    <PMID>26095785</PMID>
  </results_reference>
  <results_reference>
    <citation>Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115.</citation>
    <PMID>24563870</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>SBRT</keyword>
  <keyword>rhGM-CSF</keyword>
  <keyword>Thymosin Alpha 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunologic Factors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02976740
org study id: KYZ2016-006
nct id: NCT02976740
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)
      combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and
      Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in
      second-line chemotherapy.
Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to
      day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony
      stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle.
      Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a
      consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist
      week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be
      conducted at the end of therapy and every month after that. Adverse events will be recorded
      according to NCI-CTC version 4.03.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: abscopal effect rate
time frame: at the time point of 4 weeks after completion of the combined treatment
measure: overall survival
time frame: 1 year after completion of the combined treatment
measure: Incidence of Adverse events
time frame: 1 year after completion of the combined treatment
measure: objective response rate
time frame: 4 weeks after completion of the combined treatment
measure: Incidence of immune-related adverse events
time frame: 1 year after completion of the combined treatment
arm group label: SBRT+GM-CSF+Tα1
arm group type: Experimental
description: Metastasis lesion will be treated with a SBRT of 50Gy/4-10F from day 1 to day 10 . Subcutaneous injection of Immunological Agent- human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Subcutaneous injection of another Immunological Factors Thymosin Alpha 1(1.6mg Biw)will be executed from the fist WEEK to the 12th Weeks.
intervention type: Radiation
intervention name: SBRT
description: Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion
arm group label: SBRT+GM-CSF+Tα1
other name: SABR
intervention type: Drug
intervention name: Immunological Agent
description: Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
arm group label: SBRT+GM-CSF+Tα1
other name: rh GM-CSF
intervention type: Drug
intervention name: Immunological Factors
description: Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.
arm group label: SBRT+GM-CSF+Tα1
other name: Tα1
criteria: 
gender: All
minimum age: 17 Years
maximum age: 70 Years
healthy volunteers: No
last name: Deng Chong, MD
phone: 86-05922139531
email: dengchongxm@163.com
last name: Lin Qin, MD/PhD
phone: 86-05922139531
email: linqin03@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
citation: Twyman-Saint Victor C, Rech AJ, Maity A, Rengan R, Pauken KE, Stelekati E, Benci JL, Xu B, Dada H, Odorizzi PM, Herati RS, Mansfield KD, Patsch D, Amaravadi RK, Schuchter LM, Ishwaran H, Mick R, Pryma DA, Xu X, Feldman MD, Gangadhar TC, Hahn SM, Wherry EJ, Vonderheide RH, Minn AJ. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015 Apr 16;520(7547):373-7. doi: 10.1038/nature14292. Epub 2015 Mar 9.
PMID: 25754329
citation: Formenti SC, Demaria S. Systemic effects of local radiotherapy. Lancet Oncol. 2009 Jul;10(7):718-26. doi: 10.1016/S1470-2045(09)70082-8.
PMID: 19573801
citation: Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature. 2011 Dec 21;480(7378):480-9. doi: 10.1038/nature10673.
PMID: 22193102
citation: Zeng J, See AP, Phallen J, Jackson CM, Belcaid Z, Ruzevick J, Durham N, Meyer C, Harris TJ, Albesiano E, Pradilla G, Ford E, Wong J, Hammers HJ, Mathios D, Tyler B, Brem H, Tran PT, Pardoll D, Drake CG, Lim M. Anti-PD-1 blockade and stereotactic radiation produce long-term survival in mice with intracranial gliomas. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):343-9. doi: 10.1016/j.ijrobp.2012.12.025. Epub 2013 Feb 22.
PMID: 23462419
citation: Kalbasi A, June CH, Haas N, Vapiwala N. Radiation and immunotherapy: a synergistic combination. J Clin Invest. 2013 Jul;123(7):2756-63. doi: 10.1172/JCI69219. Epub 2013 Jul 1.
PMID: 23863633
citation: Suzuki Y, Mimura K, Yoshimoto Y, Watanabe M, Ohkubo Y, Izawa S, Murata K, Fujii H, Nakano T, Kono K. Immunogenic tumor cell death induced by chemoradiotherapy in patients with esophageal squamous cell carcinoma. Cancer Res. 2012 Aug 15;72(16):3967-76. doi: 10.1158/0008-5472.CAN-12-0851. Epub 2012 Jun 14.
PMID: 22700877
citation: Reits EA, Hodge JW, Herberts CA, Groothuis TA, Chakraborty M, Wansley EK, Camphausen K, Luiten RM, de Ru AH, Neijssen J, Griekspoor A, Mesman E, Verreck FA, Spits H, Schlom J, van Veelen P, Neefjes JJ. Radiation modulates the peptide repertoire, enhances MHC class I expression, and induces successful antitumor immunotherapy. J Exp Med. 2006 May 15;203(5):1259-71. doi: 10.1084/jem.20052494. Epub 2006 Apr 24.
PMID: 16636135
citation: Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824.
PMID: 22397654
citation: Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.
PMID: 26095785
citation: Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115.
PMID: 24563870
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Immunologic Factors
sharing ipd: No