<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/NCT04486287</url>
  </required_header>
  <id_info>
    <org_study_id>SA-SABT</org_study_id>
    <nct_id>NCT04486287</nct_id>
  </id_info>
  <brief_title>Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer</brief_title>
  <official_title>Phase II Study of PD-1 Inhibitor With Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Second Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Second Hospital</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>
      The study aim to investigator the efficacy and safety of sintilimab after Stereotactic&#xD;
      Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung&#xD;
      cancer(NSCLC), who had failed second-line systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single-arm phase II study of sintilimab after SABT for refractory&#xD;
      oligometastatic NSCLC, who had failed second-line systemic therapy.In this study, 44 patients&#xD;
      with oligometastatic NSCLC were treated with sintilimab after SABT every 3 weeks until&#xD;
      disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other&#xD;
      cessation of treatment as prescribed by the program, whichever occurs first. The primary end&#xD;
      point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review&#xD;
      Board (IRRC). An interim analysis will be conducted during the course of the study. The&#xD;
      results and reports will be provided to the Independent Data Audit Committee (IDMC), which&#xD;
      determines whether the trial is valid based on the valid cut-off value of the trial and&#xD;
      whether the study data can be submitted in advance. Make recommendations to the sponsor.&#xD;
      Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and&#xD;
      the sponsor. The responsibilities and related procedures of IDMC members will be defined in&#xD;
      the IDMC charter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>Objective Response Rate (ORR)</measure>
    <time_frame>up to 24 months after enrollment or study close.</time_frame>
    <description>ORR(RECIST 1.1 as assessed by the investigator )is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>up to 24 months after enrollment or study close.</time_frame>
    <description>Time to progression or death from initiation of Stereotactic Ablation Brachytherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>up to 24 months after enrollment or study close.</time_frame>
    <description>Defined as the time until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>up to 24 months after enrollment or study close .</time_frame>
    <description>RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related Adverse Events (AEs)</measure>
    <time_frame>From the date of randomization to 90 days after last dose of study treatment .</time_frame>
    <description>Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v4.03.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Oligometastasis</condition>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>Sintilimab Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sintilimab after Stereotactic Ablation Brachytherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sintilimab</intervention_name>
    <description>Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months.&#xD;
Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy.</description>
    <arm_group_label>Sintilimab Arm</arm_group_label>
    <other_name>Tyvyt</other_name>
    <other_name>IBI 308</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Provide written informed consent for the trial.&#xD;
&#xD;
        2.18 years of age on day of signing informed consent.&#xD;
&#xD;
        3.Completion of definitive therapy 4-12 weeks prior to enrollment. There are no specific&#xD;
        limitations on which treatment modalities can be used in the definitive setting (e.g. the&#xD;
        use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at&#xD;
        least 4 weeks prior to enrollment.&#xD;
&#xD;
        4.Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1&#xD;
        targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene&#xD;
        rearrangement.&#xD;
&#xD;
        5.Patients must have disease progression or recurrence after receiving first line systemic&#xD;
        therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based&#xD;
        chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had&#xD;
        received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced&#xD;
        disease and relapsed after 6 month or later, must have failed second-line treatment for&#xD;
        recurrent disease before enrollment.&#xD;
&#xD;
        6.ECOG PS 0-2, with expected survival over 3 months.&#xD;
&#xD;
        7.Adequate hematopoietic function, defined as: absolute neutrophil count (ANC) ≥ 1.5 x&#xD;
        10*9/L; platelet count ≥100 x 10*9/L; hemoglobin ≥90 g/L [no blood transfusion within 7&#xD;
        days or not erythropoietin (EPO) dependent].&#xD;
&#xD;
        8.Adequate liver function, defined as: total serum bilirubin ≤ 1.5 x upper limit of normal&#xD;
        (ULN); serum alanine transaminase (ALT) and aspartic transaminase (AST) ≤ 2.5 x ULN, with&#xD;
        no liver transplantation.&#xD;
&#xD;
        9.Adequate renal function, defined as: serum creatinine ≤ 1.5 x ULN or calculated&#xD;
        creatinine-clearance ≥ 60 ml/min (Cockcroft-Gault). Urine protein less than 2+ by&#xD;
        urinalysis or 24-hour urinary protein quantity &lt; 1g.&#xD;
&#xD;
        10.Adequate coagulation function, defined as: international normalized ratio (INR) or&#xD;
        prothrombin time (PT) ≤ 1.5 x ULN. For patients receiving anticoagulant therapy can be&#xD;
        enrolled if PT is within the range defined by anticoagulant therapy.&#xD;
&#xD;
        11.Myocardial enzymes are within normal range.&#xD;
&#xD;
        12.For all female patients of childbearing potential, a negative pregnancy test (either&#xD;
        urine or serum) must be obtained within 3 days before the first dose (Cycle 1, Day 1) of&#xD;
        study treatment. If a urine pregnancy test shows an unconfirmed result, a serum pregnancy&#xD;
        test must be performed.&#xD;
&#xD;
        13.All subjects of childbearing potential must agree to use efficient contraceptive methods&#xD;
        that result in a failure rate of &lt; 1% per year during the study treatment period and for at&#xD;
        least 180 days after discontinuation from study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently participating in or has participated in a study of an investigational agent&#xD;
             or using an investigational device within 4 weeks of the first dose of treatment.&#xD;
&#xD;
          2. Diagnosis of immunodeficiency or exposure to systemic steroid therapy or any other&#xD;
             form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment (Nasal or oral inhalers are permissible).&#xD;
&#xD;
          3. Prior monoclonal antibody within 4 weeks prior to study Day 1 or individuals who have&#xD;
             not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents&#xD;
             administered more than 4 weeks earlier.&#xD;
&#xD;
          4. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2&#xD;
             weeks prior to Day 1 drug administration on study or inability to recover (i.e., ≤&#xD;
             Grade 1 or at baseline) from adverse events due to a previously administered agent.&#xD;
&#xD;
          5. Note: Subjects with ≤ Grade 2 neuropathy or alopecia are exceptions to this criterion&#xD;
             and may qualify for the study.&#xD;
&#xD;
          6. Note: If subject had major surgery, they must have recovered adequately from the&#xD;
             toxicity and/or complications from the intervention prior to starting therapy.&#xD;
&#xD;
          7. Known additional malignancy that is progressing or requires active treatment.&#xD;
&#xD;
          8. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the&#xD;
             skin, non-invasive bladder tumors, or in situ cervical cancer&#xD;
&#xD;
          9. Known untreated central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis.&#xD;
&#xD;
         10. Active autoimmune disease requiring systemic treatment within the past 3 months or a&#xD;
             documented history of clinically severe autoimmune disease, or a syndrome that&#xD;
             requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or&#xD;
             resolved childhood asthma/atopy are an exception to this rule.Subjects that require&#xD;
             intermittent use of bronchodilators or local steroid injections are not excluded from&#xD;
             the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's&#xD;
             syndrome are not excluded from the study.&#xD;
&#xD;
         11. Evidence of pre-existing interstitial lung disease or active, non-infectious&#xD;
             pneumonitis.&#xD;
&#xD;
         12. Active infection requiring systemic therapy with IV antibiotics&#xD;
&#xD;
         13. History or current evidence of any condition, therapy, or laboratory abnormality that&#xD;
             might confound the results of the trial, interfere with the subject's participation&#xD;
             for the full duration of the trial, or is not in the best interest of the subject to&#xD;
             participate, in the opinion of the treating investigator.&#xD;
&#xD;
         14. Known psychiatric or substance abuse disorders that would interfere with cooperation&#xD;
             with the requirements of the trial.&#xD;
&#xD;
         15. Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment.&#xD;
&#xD;
         16. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic&#xD;
             T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other&#xD;
             antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).&#xD;
&#xD;
         17. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
         18. Known active Hepatitis B (e.g., HBsAg positive or HBV DNA detectable) or Hepatitis C&#xD;
             (e.g., HCV RNA [qualitative] is detected).&#xD;
&#xD;
         19. Receipt of live vaccine within 30 days prior to the first dose of trial treatment.&#xD;
&#xD;
         20. Progressive disease or sites of new metastasis after definitive therapy for&#xD;
             oligometastatic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BIN HUO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical Unversity Second Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BIN HUO, MD</last_name>
    <phone>+86-022-88326791</phone>
    <email>chengzi123123@163.com</email>
  </overall_contact>
  <reference>
    <citation>Bergsma DP, Salama JK, Singh DP, Chmura SJ, Milano MT. Radiotherapy for Oligometastatic Lung Cancer. Front Oncol. 2017 Sep 19;7:210. doi: 10.3389/fonc.2017.00210. eCollection 2017.</citation>
    <PMID>28975081</PMID>
  </reference>
  <reference>
    <citation>Gong HY, Wang Y, Han G, Song QB. Radiotherapy for oligometastatic tumor improved the prognosis of patients with non-small cell lung cancer (NSCLC). Thorac Cancer. 2019 May;10(5):1136-1140. doi: 10.1111/1759-7714.13054. Epub 2019 Apr 7.</citation>
    <PMID>30957423</PMID>
  </reference>
  <reference>
    <citation>Punnanitinont A, Kannisto ED, Matsuzaki J, Odunsi K, Yendamuri S, Singh AK, Patnaik SK. Sublethal Radiation Affects Antigen Processing and Presentation Genes to Enhance Immunogenicity of Cancer Cells. Int J Mol Sci. 2020 Apr 7;21(7):2573. doi: 10.3390/ijms21072573.</citation>
    <PMID>32272797</PMID>
  </reference>
  <reference>
    <citation>Shevtsov M, Sato H, Multhoff G, Shibata A. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy. Front Oncol. 2019 Mar 19;9:156. doi: 10.3389/fonc.2019.00156. eCollection 2019.</citation>
    <PMID>30941308</PMID>
  </reference>
  <reference>
    <citation>Bauml JM, Mick R, Ciunci C, Aggarwal C, Davis C, Evans T, Deshpande C, Miller L, Patel P, Alley E, Knepley C, Mutale F, Cohen RB, Langer CJ. Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial. JAMA Oncol. 2019 Sep 1;5(9):1283-1290. doi: 10.1001/jamaoncol.2019.1449.</citation>
    <PMID>31294762</PMID>
  </reference>
  <reference>
    <citation>Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.</citation>
    <PMID>31294749</PMID>
  </reference>
  <reference>
    <citation>Annede P, Cosset JM, Van Limbergen E, Deutsch E, Haie-Meder C, Chargari C. Radiobiology: Foundation and New Insights in Modeling Brachytherapy Effects. Semin Radiat Oncol. 2020 Jan;30(1):4-15. doi: 10.1016/j.semradonc.2019.08.009.</citation>
    <PMID>31727299</PMID>
  </reference>
  <reference>
    <citation>Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J. Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.</citation>
    <PMID>32036071</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PD-1 inhibitor,Brachytherapy,SABT,Oligometastatic,NSCLC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT04486287
org study id: SA-SABT
nct id: NCT04486287
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aim to investigator the efficacy and safety of sintilimab after Stereotactic
      Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung
      cancer(NSCLC), who had failed second-line systemic therapy.
This study is a single-arm phase II study of sintilimab after SABT for refractory
      oligometastatic NSCLC, who had failed second-line systemic therapy.In this study, 44 patients
      with oligometastatic NSCLC were treated with sintilimab after SABT every 3 weeks until
      disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other
      cessation of treatment as prescribed by the program, whichever occurs first. The primary end
      point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review
      Board (IRRC). An interim analysis will be conducted during the course of the study. The
      results and reports will be provided to the Independent Data Audit Committee (IDMC), which
      determines whether the trial is valid based on the valid cut-off value of the trial and
      whether the study data can be submitted in advance. Make recommendations to the sponsor.
      Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and
      the sponsor. The responsibilities and related procedures of IDMC members will be defined in
      the IDMC charter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: up to 24 months after enrollment or study close.
description: ORR(RECIST 1.1 as assessed by the investigator )is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best response.
measure: Progression-free survival (PFS)
time frame: up to 24 months after enrollment or study close.
description: Time to progression or death from initiation of Stereotactic Ablation Brachytherapy.
measure: Overall Survival(OS)
time frame: up to 24 months after enrollment or study close.
description: Defined as the time until death due to any cause.
measure: Disease Control Rate (DCR)
time frame: up to 24 months after enrollment or study close .
description: RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).
measure: Treatment-related Adverse Events (AEs)
time frame: From the date of randomization to 90 days after last dose of study treatment .
description: Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v4.03.
arm group label: Sintilimab Arm
arm group type: Experimental
description: Sintilimab after Stereotactic Ablation Brachytherapy.
intervention type: Drug
intervention name: Sintilimab
description: Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months.
Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy.
arm group label: Sintilimab Arm
other name: Tyvyt
other name: IBI 308
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BIN HUO
role: Principal Investigator
affiliation: Tianjin Medical Unversity Second Hospital
last name: BIN HUO, MD
phone: +86-022-88326791
email: chengzi123123@163.com
citation: Bergsma DP, Salama JK, Singh DP, Chmura SJ, Milano MT. Radiotherapy for Oligometastatic Lung Cancer. Front Oncol. 2017 Sep 19;7:210. doi: 10.3389/fonc.2017.00210. eCollection 2017.
PMID: 28975081
citation: Gong HY, Wang Y, Han G, Song QB. Radiotherapy for oligometastatic tumor improved the prognosis of patients with non-small cell lung cancer (NSCLC). Thorac Cancer. 2019 May;10(5):1136-1140. doi: 10.1111/1759-7714.13054. Epub 2019 Apr 7.
PMID: 30957423
citation: Punnanitinont A, Kannisto ED, Matsuzaki J, Odunsi K, Yendamuri S, Singh AK, Patnaik SK. Sublethal Radiation Affects Antigen Processing and Presentation Genes to Enhance Immunogenicity of Cancer Cells. Int J Mol Sci. 2020 Apr 7;21(7):2573. doi: 10.3390/ijms21072573.
PMID: 32272797
citation: Shevtsov M, Sato H, Multhoff G, Shibata A. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy. Front Oncol. 2019 Mar 19;9:156. doi: 10.3389/fonc.2019.00156. eCollection 2019.
PMID: 30941308
citation: Bauml JM, Mick R, Ciunci C, Aggarwal C, Davis C, Evans T, Deshpande C, Miller L, Patel P, Alley E, Knepley C, Mutale F, Cohen RB, Langer CJ. Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial. JAMA Oncol. 2019 Sep 1;5(9):1283-1290. doi: 10.1001/jamaoncol.2019.1449.
PMID: 31294762
citation: Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.
PMID: 31294749
citation: Annede P, Cosset JM, Van Limbergen E, Deutsch E, Haie-Meder C, Chargari C. Radiobiology: Foundation and New Insights in Modeling Brachytherapy Effects. Semin Radiat Oncol. 2020 Jan;30(1):4-15. doi: 10.1016/j.semradonc.2019.08.009.
PMID: 31727299
citation: Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J. Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.
PMID: 32036071
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No