<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/NCT03812549</url>
  </required_header>
  <id_info>
    <org_study_id>IHC-001</org_study_id>
    <nct_id>NCT03812549</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients</brief_title>
  <official_title>Multi-center Phase I Study of Sintilimab in Combination With Radiotherapy in Treatment Naive PD-L1 Positive Stage IV Non-small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sichuan University</source>
  <oversight_info>
    <has_dmc>Yes</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 pilot phase I trial aims to investigate the safety and tolerability of anti-programmed&#xD;
      cell death-1 (PD-1) monoclonal antibody Sintilimab (also called IBI308) in combination with&#xD;
      concurrent stereotactic body radiation therapy (SBRT) and low dose radiotherapy (LDRT) in&#xD;
      treating patients with stage IV non-small cell lung cancer (NSCLC).&#xD;
&#xD;
      At least 29 participants will be enrolled in this study. All will take part at West China&#xD;
      Hospital, Sichuan University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This exploratory phase I study will be conducted in two steps:&#xD;
&#xD;
      Step A: A low dose radiotherapy (LDRT) dose escalation, 6 patients per cohort (a total of 18&#xD;
      patients) will be enrolled to determine the maximum tolerated dose (MTD), dose-limiting&#xD;
      toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT.&#xD;
&#xD;
      Step B: A lung LDRT dose expansion&#xD;
&#xD;
      All eligible patients will receive lung SBRT dosed at 30 Gy in 3 fractions, in combination&#xD;
      with LDRT at different dose levels (decried as below) starting from the 2nd day of SBRT,&#xD;
      followed by sintilimab monotherapy starting within 7 days after radiation completed.&#xD;
      Sintilimab will be given at 200mg every 3 weeks until disease progression, unacceptable&#xD;
      toxicities, the patient withdraws informed consent, or sintilimab reaches a maximum of up to&#xD;
      24 months.&#xD;
&#xD;
      Patients in the dose escalation will receive lung LDRT at 3 cohorts with increasing dose&#xD;
      levels: 2 Gy in 1 fraction in dose level 1, 4 Gy in 2 fractions in dose level 2, 10Gy in 5&#xD;
      fractions in dose level 3.&#xD;
&#xD;
      A cohort of 17 patients will receive lung LDRT at the RDE determined during the dose&#xD;
      escalation phase in combination with SBRT and Sintilimab to obtain additional safety and&#xD;
      response data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">July 8, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <phase>Phase 1</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 Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of Sintilimab in Combination With SBRT and LDRT</measure>
    <time_frame>From the day the patient signs ICF until 30 days after last dose of sintilimab or 90 days after radiation, whichever occurs later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>up to 24 months after the enrollment</time_frame>
    <description>Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>up to 24 months after the enrollment</time_frame>
    <description>Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing LDRT and the tumor which do not receive radiotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 24 months after the enrollment</time_frame>
    <description>OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Outcome Measure1</measure>
    <time_frame>baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study</time_frame>
    <description>Circulating tumor DNA (ctDNA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Outcome Measure2</measure>
    <time_frame>baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study</time_frame>
    <description>circulating tumor cell (CTC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Outcome Measure3</measure>
    <time_frame>baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study</time_frame>
    <description>T Cell Receptor (TCR) Repertoire Diversity</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Stage IV NSCLC</condition>
  <arm_group>
    <arm_group_label>Sintilimab Combined with SBRT and LDRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A-Dose escalation cohort. DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg.&#xD;
Part-B - Expansion cohort. SBRT dose at 30 Gy/3f + LDRT + anti-PD-1 inhibitor 200mg, LDRT dose at MTD determined in Part A .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sintilimab</intervention_name>
    <description>Patients will receive treatment with Sintilimab 200mg every 3 weeks for a maximum of 24 months.</description>
    <arm_group_label>Sintilimab Combined with SBRT and LDRT</arm_group_label>
    <other_name>IBI308</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>stereotactic body radiation therapy</intervention_name>
    <description>Radiation treatment utilized in this trial consists of SBRT with a standard doses to 30 Gy/3f</description>
    <arm_group_label>Sintilimab Combined with SBRT and LDRT</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low Dose Radiotherapy</intervention_name>
    <description>LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 10 Gy/5f with conventional external beam radiation.</description>
    <arm_group_label>Sintilimab Combined with SBRT and LDRT</arm_group_label>
    <other_name>LDRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with histologically or cytologically confirmed stage IV NSCLC.&#xD;
&#xD;
          2. Enough tumor tissue samples.&#xD;
&#xD;
          3. No previous radiation, chemotherapy, immunotherapy. Patients who have received&#xD;
             neoadjuvant or adjuvant chemotherapy 12 months before enrollment is permitted.&#xD;
&#xD;
          4. At least three measurable disease according to RECIST 1.1 that meet SBRT and LDRT&#xD;
             radiation requirement as protocol defined&#xD;
&#xD;
          5. PD-L1 expression positive (TPS &gt;1%)&#xD;
&#xD;
          6. Be ≥18 years of age on day of signing informed consent and ≤75 years old.&#xD;
&#xD;
          7. ECOG 0-1.&#xD;
&#xD;
          8. Patients must have normal organ and marrow function as defined below: Total bilirubin&#xD;
             &lt;/= 1.5 mg/dL. Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase (SGOT)/&#xD;
             Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) &lt;2.5 X&#xD;
             institutional upper limit of normal (patients with liver involvement will be allowed&#xD;
             &lt;/= 5.0 X institutional upper normal limit) *WBC &gt;/= 3500/uL, ANC &gt;/= 1500/uL&#xD;
             *Platelets &gt;/= 90K *Hemoglobin &gt;/= 9g/dL *Creatinine &lt;/= 1.5 x ULN.&#xD;
&#xD;
          9. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
         10. Patients should be able to tolerate a course of radiotherapy as assessed by the&#xD;
             investigator.&#xD;
&#xD;
         11. No contradiction to radiation per radio-oncologists' judgments&#xD;
&#xD;
         12. Life expectancy of &gt; 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. EGFR/ALK/ROS-1 mutation or mutation status unknown.&#xD;
&#xD;
          2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.&#xD;
&#xD;
          3. Subjects with coronary bypass operation.&#xD;
&#xD;
          4. Subjects with insufficient heart function, liver function and kidney function.&#xD;
&#xD;
          5. Subjects with severe uncontrollable psychotic symptoms.&#xD;
&#xD;
          6. Treatment with systemic corticosteroids or other systemic immunosuppressive&#xD;
             medications (including but not limited to prednisone, dexamethasone, cyclophosphamide,&#xD;
             azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 4&#xD;
             weeks prior to enrollment or anticipated requirement for systemic immunosuppressive&#xD;
             medications during the trial.&#xD;
&#xD;
          7. Subjects with active, known or suspected autoimmune disease such as interstitial&#xD;
             pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured&#xD;
             childhood asthma, type I diabetes mellitus only requiring hormone replacement.&#xD;
&#xD;
          8. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.&#xD;
&#xD;
          9. Known hypersensitivity or allergy to monoclonal antibody.&#xD;
&#xD;
         10. Subjects with a history of interstitial lung disease.&#xD;
&#xD;
         11. Uncontrolled concomitant disease, including but not limited to :&#xD;
&#xD;
        1)Active or poorly controlled severe infection 2)Human Immunodeficiency Virus (HIV)&#xD;
        infection (HIV antibody positive) 3)Known acute or chronic active hepatitis B (HBV DNA&#xD;
        positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV&#xD;
        RNA positive) infection 4)Active tuberculosis 5)Symptomatic congestive heart failure (New&#xD;
        York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia&#xD;
        6)Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) 7)Prior arterial&#xD;
        thromboembolism event, including myocardial infarction, unstable angina, stroke and&#xD;
        transient ischemic attack, within 6 months of enrollment 8)Concomitant disease needs&#xD;
        anticoagulant therapy 9)Uncontrolled hypercalcemia（Ca2+&gt;1.5mmol/L or Ca &gt;12mg/dl or&#xD;
        corrected Serum Calcium &gt;ULN），or Symptomatic hypercalcemia during diphosphonate therapy&#xD;
&#xD;
        12. Other primary malignancy, with the exception of: (radical Non-melanoma skin cancer or&#xD;
        cured cervical in-situ carcinoma;).&#xD;
&#xD;
        13. Subjects with other diseases or abnormal Lab test results which might increase the risk&#xD;
        of enrollment and treatment or Interfere with the interpretation of study results could be&#xD;
        excluded according to the judgments of investigator.&#xD;
&#xD;
        14. Pregnant or lactating women.&#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>You Lu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sharma P, Allison JP. The future of immune checkpoint therapy. Science. 2015 Apr 3;348(6230):56-61. doi: 10.1126/science.aaa8172.</citation>
    <PMID>25838373</PMID>
  </reference>
  <reference>
    <citation>Demaria S, Coleman CN, Formenti SC. Radiotherapy: Changing the Game in Immunotherapy. Trends Cancer. 2016 Jun;2(6):286-294. doi: 10.1016/j.trecan.2016.05.002.</citation>
    <PMID>27774519</PMID>
  </reference>
  <reference>
    <citation>Kaur P, Asea A. Radiation-induced effects and the immune system in cancer. Front Oncol. 2012 Dec 17;2:191. doi: 10.3389/fonc.2012.00191. eCollection 2012.</citation>
    <PMID>23251903</PMID>
  </reference>
  <reference>
    <citation>Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.</citation>
    <PMID>26951040</PMID>
  </reference>
  <reference>
    <citation>Park SS, Dong H, Liu X, Harrington SM, Krco CJ, Grams MP, Mansfield AS, Furutani KM, Olivier KR, Kwon ED. PD-1 Restrains Radiotherapy-Induced Abscopal Effect. Cancer Immunol Res. 2015 Jun;3(6):610-9. doi: 10.1158/2326-6066.CIR-14-0138. Epub 2015 Feb 19.</citation>
    <PMID>25701325</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>
  <reference>
    <citation>Du J, Su S, Li H, Shao J, Meng F, Yang M, Qian H, Zou Z, Qian X, Liu B. Low dose irradiation increases adoptive cytotoxic T lymphocyte migration in gastric cancer. Exp Ther Med. 2017 Dec;14(6):5711-5716. doi: 10.3892/etm.2017.5305. Epub 2017 Oct 13.</citation>
    <PMID>29285113</PMID>
  </reference>
  <reference>
    <citation>Brooks ED, Chang JY. Time to abandon single-site irradiation for inducing abscopal effects. Nat Rev Clin Oncol. 2019 Feb;16(2):123-135. doi: 10.1038/s41571-018-0119-7.</citation>
    <PMID>30401936</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sichuan University</investigator_affiliation>
    <investigator_full_name>You Lu</investigator_full_name>
    <investigator_title>Chair of Department of Thoracic Oncology</investigator_title>
  </responsible_party>
  <keyword>Immunotherapy;SBRT; PD-L1 positive; LDRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_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/NCT03812549
org study id: IHC-001
nct id: NCT03812549
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot phase I trial aims to investigate the safety and tolerability of anti-programmed
      cell death-1 (PD-1) monoclonal antibody Sintilimab (also called IBI308) in combination with
      concurrent stereotactic body radiation therapy (SBRT) and low dose radiotherapy (LDRT) in
      treating patients with stage IV non-small cell lung cancer (NSCLC).

      At least 29 participants will be enrolled in this study. All will take part at West China
      Hospital, Sichuan University.
This exploratory phase I study will be conducted in two steps:

      Step A: A low dose radiotherapy (LDRT) dose escalation, 6 patients per cohort (a total of 18
      patients) will be enrolled to determine the maximum tolerated dose (MTD), dose-limiting
      toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT.

      Step B: A lung LDRT dose expansion

      All eligible patients will receive lung SBRT dosed at 30 Gy in 3 fractions, in combination
      with LDRT at different dose levels (decried as below) starting from the 2nd day of SBRT,
      followed by sintilimab monotherapy starting within 7 days after radiation completed.
      Sintilimab will be given at 200mg every 3 weeks until disease progression, unacceptable
      toxicities, the patient withdraws informed consent, or sintilimab reaches a maximum of up to
      24 months.

      Patients in the dose escalation will receive lung LDRT at 3 cohorts with increasing dose
      levels: 2 Gy in 1 fraction in dose level 1, 4 Gy in 2 fractions in dose level 2, 10Gy in 5
      fractions in dose level 3.

      A cohort of 17 patients will receive lung LDRT at the RDE determined during the dose
      escalation phase in combination with SBRT and Sintilimab to obtain additional safety and
      response data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of Sintilimab in Combination With SBRT and LDRT
time frame: From the day the patient signs ICF until 30 days after last dose of sintilimab or 90 days after radiation, whichever occurs later
measure: Progression Free Survival (PFS)
time frame: up to 24 months after the enrollment
description: Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease.
measure: Objective Response Rate (ORR)
time frame: up to 24 months after the enrollment
description: Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing LDRT and the tumor which do not receive radiotherapy.
measure: Overall Survival (OS)
time frame: up to 24 months after the enrollment
description: OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause
measure: Exploratory Outcome Measure1
time frame: baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study
description: Circulating tumor DNA (ctDNA)
measure: Exploratory Outcome Measure2
time frame: baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study
description: circulating tumor cell (CTC)
measure: Exploratory Outcome Measure3
time frame: baseline, after radiation, and every 2 cycles of sintilimab, up to 24 months until end of study
description: T Cell Receptor (TCR) Repertoire Diversity
arm group label: Sintilimab Combined with SBRT and LDRT
arm group type: Experimental
description: Part A-Dose escalation cohort. DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg.
Part-B - Expansion cohort. SBRT dose at 30 Gy/3f + LDRT + anti-PD-1 inhibitor 200mg, LDRT dose at MTD determined in Part A .
intervention type: Drug
intervention name: Sintilimab
description: Patients will receive treatment with Sintilimab 200mg every 3 weeks for a maximum of 24 months.
arm group label: Sintilimab Combined with SBRT and LDRT
other name: IBI308
intervention type: Radiation
intervention name: stereotactic body radiation therapy
description: Radiation treatment utilized in this trial consists of SBRT with a standard doses to 30 Gy/3f
arm group label: Sintilimab Combined with SBRT and LDRT
other name: SBRT
intervention type: Radiation
intervention name: Low Dose Radiotherapy
description: LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 10 Gy/5f with conventional external beam radiation.
arm group label: Sintilimab Combined with SBRT and LDRT
other name: LDRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: You Lu, MD
role: Principal Investigator
affiliation: West China Hospital
facility: 
country: China
citation: Sharma P, Allison JP. The future of immune checkpoint therapy. Science. 2015 Apr 3;348(6230):56-61. doi: 10.1126/science.aaa8172.
PMID: 25838373
citation: Demaria S, Coleman CN, Formenti SC. Radiotherapy: Changing the Game in Immunotherapy. Trends Cancer. 2016 Jun;2(6):286-294. doi: 10.1016/j.trecan.2016.05.002.
PMID: 27774519
citation: Kaur P, Asea A. Radiation-induced effects and the immune system in cancer. Front Oncol. 2012 Dec 17;2:191. doi: 10.3389/fonc.2012.00191. eCollection 2012.
PMID: 23251903
citation: Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.
PMID: 26951040
citation: Park SS, Dong H, Liu X, Harrington SM, Krco CJ, Grams MP, Mansfield AS, Furutani KM, Olivier KR, Kwon ED. PD-1 Restrains Radiotherapy-Induced Abscopal Effect. Cancer Immunol Res. 2015 Jun;3(6):610-9. doi: 10.1158/2326-6066.CIR-14-0138. Epub 2015 Feb 19.
PMID: 25701325
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: Du J, Su S, Li H, Shao J, Meng F, Yang M, Qian H, Zou Z, Qian X, Liu B. Low dose irradiation increases adoptive cytotoxic T lymphocyte migration in gastric cancer. Exp Ther Med. 2017 Dec;14(6):5711-5716. doi: 10.3892/etm.2017.5305. Epub 2017 Oct 13.
PMID: 29285113
citation: Brooks ED, Chang JY. Time to abandon single-site irradiation for inducing abscopal effects. Nat Rev Clin Oncol. 2019 Feb;16(2):123-135. doi: 10.1038/s41571-018-0119-7.
PMID: 30401936
responsible party type: Principal Investigator
investigator affiliation: Sichuan University
investigator full name: You Lu
investigator title: Chair of Department of Thoracic Oncology
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No