<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/NCT04404491</url>
  </required_header>
  <id_info>
    <org_study_id>ITCRTECR</org_study_id>
    <nct_id>NCT04404491</nct_id>
  </id_info>
  <brief_title>Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence</brief_title>
  <official_title>The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Henan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Henan University of Science and Technology</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Esophageal cancer is still a serious threat to human life and health. China in particular.&#xD;
      Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new&#xD;
      treatment method, which can be used in combination with chemotherapy to improve the&#xD;
      therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in&#xD;
      concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our&#xD;
      team will study it in detail.&#xD;
&#xD;
      The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent&#xD;
      chemoradiotherapy of locally recurrent esophageal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients with local recurrence of esophageal carcinoma without distant&#xD;
      metastasis were randomly divided into experimental group and control group by Block&#xD;
      randomization. In the experimental group, patients with local recurrence were treated with&#xD;
      Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe&#xD;
      the objective remission rate and disease-free survival. In the control group, patients with&#xD;
      local recurrence were treated with placebo combined with concurrent chemoradiotherapy.&#xD;
      Followed up for 3 years to observe the objective remission rate and disease-free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <phase>Phase 3</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>Grade 3/4 acute toxicities</measure>
    <time_frame>90 days</time_frame>
    <description>rade 3/4 acute toxicities occurred during or within 90 days after CRT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>1 year</time_frame>
    <description>Progression Free Survival After completion of the CRT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>16 weeks</time_frame>
    <description>overall remission rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS Qol</measure>
    <time_frame>1 year</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Esophageal Malignant Neoplasm, Local Recurrence</condition>
  <arm_group>
    <arm_group_label>PD-1 and Concurrent chemoradiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo and Concurrent chemoradiotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Procedural death 1</intervention_name>
    <description>200mg,d1,15,29,43,57,I.V</description>
    <arm_group_label>PD-1 and Concurrent chemoradiotherapy</arm_group_label>
    <other_name>Camrelizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.</description>
    <arm_group_label>PD-1 and Concurrent chemoradiotherapy</arm_group_label>
    <arm_group_label>placebo and Concurrent chemoradiotherapy</arm_group_label>
    <other_name>Aibin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.</description>
    <arm_group_label>PD-1 and Concurrent chemoradiotherapy</arm_group_label>
    <arm_group_label>placebo and Concurrent chemoradiotherapy</arm_group_label>
    <other_name>Radiation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo: 200mg,d1,15,29,43,57,I.V</description>
    <arm_group_label>placebo and Concurrent chemoradiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophageal&#xD;
        squamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stage&#xD;
        II-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurable&#xD;
        lesion; 5. ECOG: 0 ～ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of main&#xD;
        organs is normal, that is, it meets the following standards: Blood routine examination:a.&#xD;
        HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L;3.Biochemical inspection:a.ALB ≥ 30g /&#xD;
        L; b. ALT and AST ≤ 2.5ULN; c. TBIL ≤ 1.5ULN; 8. Women of childbearing age should agree to&#xD;
        use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during&#xD;
        the study period and within 6 months after the end of the study; the serum or urine&#xD;
        pregnancy test is negative within 7 days before the study enrollment , and must be a&#xD;
        non-lactating patient; males should agree to patients who must use contraception during the&#xD;
        study period and within 6 months after the end of the study period; 9. Subjects voluntarily&#xD;
        joined the study, signed an informed consent form, had good compliance, and cooperated with&#xD;
        follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Does not meet the above selection criteria;&#xD;
&#xD;
          2. Patients with distant metastases;&#xD;
&#xD;
          3. Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;&#xD;
&#xD;
          4. The patient has any active autoimmune disease or has a history of autoimmune disease&#xD;
             (such as the following, but not limited to: autoimmune hepatitis, interstitial&#xD;
             pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,&#xD;
             nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completely&#xD;
             relieved in childhood and can be included without any intervention after adulthood;&#xD;
             Patients with asthma requiring medical intervention with bronchodilators cannot be&#xD;
             included);&#xD;
&#xD;
          5. The patient is using immunosuppressive agents or systemic hormone therapy to achieve&#xD;
             the purpose of immunosuppression (dose&gt; 10mg / day prednisone or other therapeutic&#xD;
             hormones), and is still using it within 2 weeks before enrollment; 6.&#xD;
             Contraindications to radiotherapy;&#xD;
&#xD;
        7. Severe infections that are active or uncontrolled; 8. Liver diseases such as&#xD;
        decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or&#xD;
        hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical&#xD;
        method; 9. Patients whose imaging has shown that the tumor has invaded the important blood&#xD;
        vessels or the investigator judges that the tumor is likely to invade the important blood&#xD;
        vessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactating&#xD;
        women; 11. Patients with other malignant tumors within 5 years (except basal cell carcinoma&#xD;
        of the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropic&#xD;
        substance abuse who are unable to quit or have mental disorders; 13. Patients who have&#xD;
        participated in clinical trials of other drugs within four weeks; 14. According to the&#xD;
        judgment of the investigator, there are patients with concomitant diseases that seriously&#xD;
        endanger the safety of the patient or affect the completion of the study; 15. The&#xD;
        investigator considers it unsuitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shegan Gao, M.D,Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Henan University of Science and Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shegan Gao, M.D,Ph.D</last_name>
    <phone>18638859977</phone>
    <email>gsg112258@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tanyou Shan, M.D,M.S</last_name>
    <phone>18537976669</phone>
    <email>shantanyou@163.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Nakajima T, Ogata T, Nomiya T, Nonaka T, Nakayama Y, Kano K, Maezawa Y, Segami K, Ikeda K, Sato T, Cho H, Yoshikawa T. [Radical Chemoradiotherapy for Recurrent Esophageal Cancer after Curative Esophagectomy]. Gan To Kagaku Ryoho. 2016 Nov;43(12):1564-1566. Japanese.</citation>
    <PMID>28133058</PMID>
  </reference>
  <reference>
    <citation>Zhu LL, Yuan L, Wang H, Ye L, Yao GY, Liu C, Sun NN, Li XJ, Zhai SC, Niu LJ, Zhang JB, Ji HL, Li XM. A Meta-Analysis of Concurrent Chemoradiotherapy for Advanced Esophageal Cancer. PLoS One. 2015 Jun 5;10(6):e0128616. doi: 10.1371/journal.pone.0128616. eCollection 2015.</citation>
    <PMID>26046353</PMID>
  </reference>
  <reference>
    <citation>Jingu K, Umezawa R, Yamamoto T, Matsushita H, Ishikawa Y, Kozumi M, Kubozono M, Takahashi N, Kadoya N, Takeda K. Elective nodal irradiation is not necessary in chemoradiotherapy for postoperative loco-regional recurrent esophageal cancer. Jpn J Clin Oncol. 2017 Mar 1;47(3):200-205. doi: 10.1093/jjco/hyw195.</citation>
    <PMID>28031356</PMID>
  </reference>
  <reference>
    <citation>Fassan M, Cavallin F, Guzzardo V, Kotsafti A, Scarpa M, Cagol M, Chiarion-Sileni V, Maria Saadeh L, Alfieri R, Castagliuolo I, Rugge M, Castoro C, Scarpa M. PD-L1 expression, CD8+ and CD4+ lymphocyte rate are predictive of pathological complete response after neoadjuvant chemoradiotherapy for squamous cell cancer of the thoracic esophagus. Cancer Med. 2019 Oct;8(13):6036-6048. doi: 10.1002/cam4.2359. Epub 2019 Aug 20.</citation>
    <PMID>31429521</PMID>
  </reference>
  <reference>
    <citation>Sato D, Motegi A, Kadota T, Kojima T, Bando H, Shinmura K, Hori K, Yoda Y, Oono Y, Zenda S, Ikematsu H, Akimoto T, Yano T. Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence. Esophagus. 2020 Jul;17(3):305-311. doi: 10.1007/s10388-020-00715-y. Epub 2020 Jan 21.</citation>
    <PMID>31965362</PMID>
  </reference>
  <reference>
    <citation>Chen B, Li Q, Li Q, Qiu B, Xi M, Liu M, Hu Y, Zhu Y. Weekly Chemotherapy of 5-Fluorouracil plus Cisplatin Concurrent with Radiotherapy for Esophageal Squamous Cell Carcinoma Patients with Postoperative Locoregional Recurrence: Results from a Phase II Study. Oncologist. 2020 Apr;25(4):308-e625. doi: 10.1634/theoncologist.2019-0931. Epub 2019 Dec 27.</citation>
    <PMID>31880371</PMID>
  </reference>
  <reference>
    <citation>Kelly RJ. Immunotherapy for Esophageal and Gastric Cancer. Am Soc Clin Oncol Educ Book. 2017;37:292-300. doi: 10.1200/EDBK_175231.</citation>
    <PMID>28561677</PMID>
  </reference>
  <reference>
    <citation>Yang H, Wang K, Wang T, Li M, Li B, Li S, Yuan L. The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer. Front Oncol. 2020 Mar 5;10:300. doi: 10.3389/fonc.2020.00300. eCollection 2020.</citation>
    <PMID>32195194</PMID>
  </reference>
  <reference>
    <citation>Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.</citation>
    <PMID>30735435</PMID>
  </reference>
  <reference>
    <citation>Svensson MC, Borg D, Zhang C, Hedner C, Nodin B, Uhlen M, Mardinoglu A, Leandersson K, Jirstrom K. Expression of PD-L1 and PD-1 in Chemoradiotherapy-Naive Esophageal and Gastric Adenocarcinoma: Relationship With Mismatch Repair Status and Survival. Front Oncol. 2019 Mar 13;9:136. doi: 10.3389/fonc.2019.00136. eCollection 2019.</citation>
    <PMID>30931254</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carrillizumab</keyword>
  <keyword>Esophageal cancer recurred</keyword>
  <keyword>concurrent radiochemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</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/NCT04404491
org study id: ITCRTECR
nct id: NCT04404491
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Esophageal cancer is still a serious threat to human life and health. China in particular.
      Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new
      treatment method, which can be used in combination with chemotherapy to improve the
      therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in
      concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our
      team will study it in detail.

      The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent
      chemoradiotherapy of locally recurrent esophageal cancer.
In this study, patients with local recurrence of esophageal carcinoma without distant
      metastasis were randomly divided into experimental group and control group by Block
      randomization. In the experimental group, patients with local recurrence were treated with
      Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe
      the objective remission rate and disease-free survival. In the control group, patients with
      local recurrence were treated with placebo combined with concurrent chemoradiotherapy.
      Followed up for 3 years to observe the objective remission rate and disease-free survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Grade 3/4 acute toxicities
time frame: 90 days
description: rade 3/4 acute toxicities occurred during or within 90 days after CRT
measure: PFS
time frame: 1 year
description: Progression Free Survival After completion of the CRT
measure: ORR
time frame: 16 weeks
description: overall remission rate
measure: OS Qol
time frame: 1 year
description: overall survival
arm group label: PD-1 and Concurrent chemoradiotherapy
arm group type: Active Comparator
description: Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
arm group label: placebo and Concurrent chemoradiotherapy
arm group type: Placebo Comparator
description: placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
intervention type: Drug
intervention name: Procedural death 1
description: 200mg,d1,15,29,43,57,I.V
arm group label: PD-1 and Concurrent chemoradiotherapy
other name: Camrelizumab
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.
arm group label: PD-1 and Concurrent chemoradiotherapy
arm group label: placebo and Concurrent chemoradiotherapy
other name: Aibin
intervention type: Radiation
intervention name: Radiotherapy
description: radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
arm group label: PD-1 and Concurrent chemoradiotherapy
arm group label: placebo and Concurrent chemoradiotherapy
other name: Radiation Therapy
intervention type: Drug
intervention name: Placebo
description: placebo: 200mg,d1,15,29,43,57,I.V
arm group label: placebo and Concurrent chemoradiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shegan Gao, M.D,Ph.D
role: Study Chair
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
last name: Shegan Gao, M.D,Ph.D
phone: 18638859977
email: gsg112258@163.com
last name: Tanyou Shan, M.D,M.S
phone: 18537976669
email: shantanyou@163.com
citation: Nakajima T, Ogata T, Nomiya T, Nonaka T, Nakayama Y, Kano K, Maezawa Y, Segami K, Ikeda K, Sato T, Cho H, Yoshikawa T. [Radical Chemoradiotherapy for Recurrent Esophageal Cancer after Curative Esophagectomy]. Gan To Kagaku Ryoho. 2016 Nov;43(12):1564-1566. Japanese.
PMID: 28133058
citation: Zhu LL, Yuan L, Wang H, Ye L, Yao GY, Liu C, Sun NN, Li XJ, Zhai SC, Niu LJ, Zhang JB, Ji HL, Li XM. A Meta-Analysis of Concurrent Chemoradiotherapy for Advanced Esophageal Cancer. PLoS One. 2015 Jun 5;10(6):e0128616. doi: 10.1371/journal.pone.0128616. eCollection 2015.
PMID: 26046353
citation: Jingu K, Umezawa R, Yamamoto T, Matsushita H, Ishikawa Y, Kozumi M, Kubozono M, Takahashi N, Kadoya N, Takeda K. Elective nodal irradiation is not necessary in chemoradiotherapy for postoperative loco-regional recurrent esophageal cancer. Jpn J Clin Oncol. 2017 Mar 1;47(3):200-205. doi: 10.1093/jjco/hyw195.
PMID: 28031356
citation: Fassan M, Cavallin F, Guzzardo V, Kotsafti A, Scarpa M, Cagol M, Chiarion-Sileni V, Maria Saadeh L, Alfieri R, Castagliuolo I, Rugge M, Castoro C, Scarpa M. PD-L1 expression, CD8+ and CD4+ lymphocyte rate are predictive of pathological complete response after neoadjuvant chemoradiotherapy for squamous cell cancer of the thoracic esophagus. Cancer Med. 2019 Oct;8(13):6036-6048. doi: 10.1002/cam4.2359. Epub 2019 Aug 20.
PMID: 31429521
citation: Sato D, Motegi A, Kadota T, Kojima T, Bando H, Shinmura K, Hori K, Yoda Y, Oono Y, Zenda S, Ikematsu H, Akimoto T, Yano T. Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence. Esophagus. 2020 Jul;17(3):305-311. doi: 10.1007/s10388-020-00715-y. Epub 2020 Jan 21.
PMID: 31965362
citation: Chen B, Li Q, Li Q, Qiu B, Xi M, Liu M, Hu Y, Zhu Y. Weekly Chemotherapy of 5-Fluorouracil plus Cisplatin Concurrent with Radiotherapy for Esophageal Squamous Cell Carcinoma Patients with Postoperative Locoregional Recurrence: Results from a Phase II Study. Oncologist. 2020 Apr;25(4):308-e625. doi: 10.1634/theoncologist.2019-0931. Epub 2019 Dec 27.
PMID: 31880371
citation: Kelly RJ. Immunotherapy for Esophageal and Gastric Cancer. Am Soc Clin Oncol Educ Book. 2017;37:292-300. doi: 10.1200/EDBK_175231.
PMID: 28561677
citation: Yang H, Wang K, Wang T, Li M, Li B, Li S, Yuan L. The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer. Front Oncol. 2020 Mar 5;10:300. doi: 10.3389/fonc.2020.00300. eCollection 2020.
PMID: 32195194
citation: Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.
PMID: 30735435
citation: Svensson MC, Borg D, Zhang C, Hedner C, Nodin B, Uhlen M, Mardinoglu A, Leandersson K, Jirstrom K. Expression of PD-L1 and PD-1 in Chemoradiotherapy-Naive Esophageal and Gastric Adenocarcinoma: Relationship With Mismatch Repair Status and Survival. Front Oncol. 2019 Mar 13;9:136. doi: 10.3389/fonc.2019.00136. eCollection 2019.
PMID: 30931254
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Neoplasms
mesh term: Recurrence
mesh term: Capecitabine
sharing ipd: No