xml: <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/NCT05978193</url>
    </required_header>
    <id_info>
      <org_study_id>SCR-ESCC-01</org_study_id>
      <nct_id>NCT05978193</nct_id>
    </id_info>
    <brief_title>Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma</brief_title>
    <official_title>First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center, Randomized Trial (SCR-ESCC-01)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Chest Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Chest 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>
        SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of&#xD;
        early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated&#xD;
        radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes&#xD;
        to alleviate the symptom of dysphagia. Recent studies have shown that the combination of&#xD;
        radiotherapy and immunotherapy may have a synergistic effect on treatment outcomes. The study&#xD;
        aims to investigate the benefit of LDRT in combination with conventionally fractionated&#xD;
        radiotherapy (CFRT) in improving the outcome of metastatic ESCC concurrently treated with&#xD;
        first-line immunochemotherapy. The recruited patients will be randomly (1:1) assigned to&#xD;
        receive either PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) (arm B) or&#xD;
        in combination with LDRT and CFRT (arm A). The primary endpoint is median progression-free&#xD;
        survival (PFS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PFS</measure>
      <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months</time_frame>
      <description>Progression-free survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>From date of randomization until the date of death from any cause, assessed up to 36 months</time_frame>
      <description>Median overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Grade III and higher treatment-related adverse events</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <condition>Esophageal Cancer</condition>
    <condition>Metastatic Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>LDRT+CFRT</intervention_name>
      <description>LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles&#xD;
  ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle</description>
      <arm_group_label>Arm A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Immunotherapy</intervention_name>
      <description>PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years</description>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chemotherapy</intervention_name>
      <description>Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles</description>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18;&#xD;
  &#xD;
            2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;&#xD;
  &#xD;
            3. ECOG performance status: 0-1 point;&#xD;
  &#xD;
            4. No prior anti-tumor treatment;&#xD;
  &#xD;
            5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements&#xD;
               for chemotherapy and immunotherapy assessed by investigators.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of&#xD;
               esophageal cancer;&#xD;
  &#xD;
            2. Patients who are potentially curable with surgery as assessed by investigators;&#xD;
  &#xD;
            3. Pleural metastasis or malignant pleural effusion, pericardial effusion;&#xD;
  &#xD;
            4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy,&#xD;
               chemotherapy, or immunotherapy;&#xD;
  &#xD;
            5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation;&#xD;
  &#xD;
            6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;&#xD;
  &#xD;
            7. Unstable cardiac diseases or symptoms;&#xD;
  &#xD;
            8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary&#xD;
               fibrosis, or other uncontrolled acute pulmonary disease;&#xD;
  &#xD;
            9. Active autoimmune disease or history of autoimmune disease;&#xD;
  &#xD;
           10. Conditions of immunodeficiency or active infection requiring systemic therapy;&#xD;
  &#xD;
           11. Pregnant or breastfeeding;&#xD;
  &#xD;
           12. Patients with synchronous second primary cancer and a history of malignancy within the&#xD;
               past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or&#xD;
               squamous cell skin carcinoma).&#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>Wen Yu, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Chest Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wen Yu, M.D</last_name>
      <phone>021-22200000-3203</phone>
      <email>yuzhiwen0827@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Ruijin Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sheng-guang Zhao</last_name>
        <phone>021-34186000</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Chest Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wen Yu</last_name>
        <phone>021-22200000-3203</phone>
        <email>yuzhiwen0827@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. Erratum In: Lancet. 2021 Nov 20;398(10314):1874.</citation>
      <PMID>34454674</PMID>
    </reference>
    <reference>
      <citation>Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.</citation>
      <PMID>34519801</PMID>
    </reference>
    <reference>
      <citation>Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.</citation>
      <PMID>35440464</PMID>
    </reference>
    <reference>
      <citation>Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.</citation>
      <PMID>35245446</PMID>
    </reference>
    <reference>
      <citation>Herrera FG, Bourhis J, Coukos G. Radiotherapy combination opportunities leveraging immunity for the next oncology practice. CA Cancer J Clin. 2017 Jan;67(1):65-85. doi: 10.3322/caac.21358. Epub 2016 Aug 29.</citation>
      <PMID>27570942</PMID>
    </reference>
    <reference>
      <citation>Shaverdian N, Lisberg AE, Bornazyan K, Veruttipong D, Goldman JW, Formenti SC, Garon EB, Lee P. Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial. Lancet Oncol. 2017 Jul;18(7):895-903. doi: 10.1016/S1470-2045(17)30380-7. Epub 2017 May 24. Erratum In: Lancet Oncol. 2017 Jul;18(7):e371.</citation>
      <PMID>28551359</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>Herrera FG, Ronet C, Ochoa de Olza M, Barras D, Crespo I, Andreatta M, Corria-Osorio J, Spill A, Benedetti F, Genolet R, Orcurto A, Imbimbo M, Ghisoni E, Navarro Rodrigo B, Berthold DR, Sarivalasis A, Zaman K, Duran R, Dromain C, Prior J, Schaefer N, Bourhis J, Dimopoulou G, Tsourti Z, Messemaker M, Smith T, Warren SE, Foukas P, Rusakiewicz S, Pittet MJ, Zimmermann S, Sempoux C, Dafni U, Harari A, Kandalaft LE, Carmona SJ, Dangaj Laniti D, Irving M, Coukos G. Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy. Cancer Discov. 2022 Jan;12(1):108-133. doi: 10.1158/2159-8290.CD-21-0003. Epub 2021 Sep 3.</citation>
      <PMID>34479871</PMID>
    </reference>
    <reference>
      <citation>Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.</citation>
      <PMID>32417411</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
      <investigator_full_name>Wen Yu</investigator_full_name>
      <investigator_title>Vice Director of Radiation Oncology Department</investigator_title>
    </responsible_party>
    <keyword>Immunotherapy</keyword>
    <keyword>low-dose radiotherapy</keyword>
    <keyword>Esophageal squamous cell carcinoma</keyword>
    <keyword>Immunoradiotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978193
  org study id: SCR-ESCC-01
  nct id: NCT05978193
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of
        early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated
        radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC.
  In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes
        to alleviate the symptom of dysphagia. Recent studies have shown that the combination of
        radiotherapy and immunotherapy may have a synergistic effect on treatment outcomes. The study
        aims to investigate the benefit of LDRT in combination with conventionally fractionated
        radiotherapy (CFRT) in improving the outcome of metastatic ESCC concurrently treated with
        first-line immunochemotherapy. The recruited patients will be randomly (1:1) assigned to
        receive either PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) (arm B) or
        in combination with LDRT and CFRT (arm A). The primary endpoint is median progression-free
        survival (PFS).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PFS
  time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
  description: Progression-free survival
  measure: OS
  time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
  description: Median overall survival
  measure: Incidence of Grade III and higher treatment-related adverse events
  time frame: 1 year
  arm group label: Arm A
  arm group type: Experimental
  description: PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
  arm group label: Arm B
  arm group type: Active Comparator
  description: PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
  intervention type: Radiation
  intervention name: LDRT+CFRT
  description: LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles
  ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle
  arm group label: Arm A
  intervention type: Drug
  intervention name: Immunotherapy
  description: PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years
  arm group label: Arm A
  arm group label: Arm B
  intervention type: Drug
  intervention name: Chemotherapy
  description: Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles
  arm group label: Arm A
  arm group label: Arm B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wen Yu, M.D
  role: Principal Investigator
  affiliation: Shanghai Chest Hospital
  last name: Wen Yu, M.D
  phone: 021-22200000-3203
  email: yuzhiwen0827@163.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. Erratum In: Lancet. 2021 Nov 20;398(10314):1874.
  PMID: 34454674
  citation: Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
  PMID: 34519801
  citation: Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.
  PMID: 35440464
  citation: Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.
  PMID: 35245446
  citation: Herrera FG, Bourhis J, Coukos G. Radiotherapy combination opportunities leveraging immunity for the next oncology practice. CA Cancer J Clin. 2017 Jan;67(1):65-85. doi: 10.3322/caac.21358. Epub 2016 Aug 29.
  PMID: 27570942
  citation: Shaverdian N, Lisberg AE, Bornazyan K, Veruttipong D, Goldman JW, Formenti SC, Garon EB, Lee P. Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial. Lancet Oncol. 2017 Jul;18(7):895-903. doi: 10.1016/S1470-2045(17)30380-7. Epub 2017 May 24. Erratum In: Lancet Oncol. 2017 Jul;18(7):e371.
  PMID: 28551359
  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: Herrera FG, Ronet C, Ochoa de Olza M, Barras D, Crespo I, Andreatta M, Corria-Osorio J, Spill A, Benedetti F, Genolet R, Orcurto A, Imbimbo M, Ghisoni E, Navarro Rodrigo B, Berthold DR, Sarivalasis A, Zaman K, Duran R, Dromain C, Prior J, Schaefer N, Bourhis J, Dimopoulou G, Tsourti Z, Messemaker M, Smith T, Warren SE, Foukas P, Rusakiewicz S, Pittet MJ, Zimmermann S, Sempoux C, Dafni U, Harari A, Kandalaft LE, Carmona SJ, Dangaj Laniti D, Irving M, Coukos G. Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy. Cancer Discov. 2022 Jan;12(1):108-133. doi: 10.1158/2159-8290.CD-21-0003. Epub 2021 Sep 3.
  PMID: 34479871
  citation: Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.
  PMID: 32417411
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Chest Hospital
  investigator full name: Wen Yu
  investigator title: Vice Director of Radiation Oncology Department
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Immunomodulating Agents
  sharing ipd: No