<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/NCT04447326</url>
  </required_header>
  <id_info>
    <org_study_id>FirstGuangxiMU1</org_study_id>
    <nct_id>NCT04447326</nct_id>
  </id_info>
  <brief_title>Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy for Nasopharyngeal Carcinoma</brief_title>
  <official_title>Randomized Controlled, Multicenter Phase II Clinical Research of Toripalimab (PD-1 Inhibitor) and Endostar Combined With Radiotherapy and Chemotherapy in the Treatment of High-risk Locally Advanced Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital Of Guizhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fourth Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LiuZhou People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guilin Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Afﬁliated Hospital of North Sichuan Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Guangxi Medical University</source>
  <oversight_info>
    <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>
      This study is to investigate the efficacy and safety of the induction chemotherapy +&#xD;
      concurrent chemoradiotherapy（CCRT）combined with toripalimab and endostar treatment, in&#xD;
      comparison with the induction chemotherapy + concurrent chemoradiotherapy（CCRT）, in treating&#xD;
      locally advanced high-risk nasopharyngeal carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GP-induced chemotherapy combined with concurrent chemoradiotherapy is the standard treatment&#xD;
      for the locally advanced nasopharyngeal carcinoma recommended by the guidelines. However, the&#xD;
      prognosis for T4 and/or N3 nasopharyngeal carcinoma is still poor, with the 3-year PFS of&#xD;
      about 70%. Therefore, it is of great importance to improve the prognosis of patients with&#xD;
      locally advanced high-risk nasopharyngeal carcinoma. Immunotherapy has been an emerging&#xD;
      treatment method for tumors in recent years. Compared with the chemotherapy, immunotherapy&#xD;
      has less adverse reactions, and the effects could last longer, significantly improving the&#xD;
      prognosis and patients' quality of life. Endostar, as a VEGFR inhibitor, has good safety in&#xD;
      treating nasopharyngeal carcinoma. Related data have shown that PD-1 and Endostar exert&#xD;
      synergistic antitumor effects in a mouse model of lung cancer. A Phase II multi-center&#xD;
      clinical study from our center has shown that, for patients with locally advanced low-risk&#xD;
      nasopharyngeal carcinoma, all the 3-year OS, PFS, and DMFS for the radiotherapy combined with&#xD;
      Endostar group were superior to the concurrent chemoradiotherapy group, and the combination&#xD;
      of radiotherapy and Endostar lead to significantly reduced adverse effects. In clinical&#xD;
      studies concerning other solid tumors, it has also been observed that the PD-1 inhibitors&#xD;
      combined with VEGFR inhibitors could significantly improve the efficacy, and achieve&#xD;
      synergistic effects. Therefore, A Phase II，randomized, prospective, multicentric clinical&#xD;
      trail was conducted to compare the efficacy and safety of induction chemotherapy and the&#xD;
      concurrent chemoradiotherapy plus Endostar and PD-1, followed by PD-1 treatment for half a&#xD;
      year compared with the induction chemotherapy and the concurrent chemoradiotherapy for the T4&#xD;
      and/or N3 nasopharyngeal carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>progression-free survival, PFS</measure>
    <time_frame>3 years</time_frame>
    <description>calculated from the date of randomisation to the date of the documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. distant failure, or death from any cause, whichever occurred first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival，OS</measure>
    <time_frame>3 years</time_frame>
    <description>the time from random assignment to death from any cause or censored at the date of last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>locoregional relapse-free Survival, LRFS</measure>
    <time_frame>3 years</time_frame>
    <description>the time from random assignment to local or regional relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival,DMFS</measure>
    <time_frame>3 years</time_frame>
    <description>calculated from date of randomisation to the first distant failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>3 months</time_frame>
    <description>complete response (CR) + partial response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events (AEs) and severe adverse events (SAE)</measure>
    <time_frame>3 years</time_frame>
    <description>graded according to NCI CTCAE 5.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>IC＋CCRT＋Toripalimab＋Endostar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w; Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles; Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IC＋CCRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy</intervention_name>
    <description>Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles</description>
    <arm_group_label>IC＋CCRT＋Toripalimab＋Endostar</arm_group_label>
    <other_name>JS001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IC＋CCRT</intervention_name>
    <description>IC＋CCRT</description>
    <arm_group_label>IC＋CCRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. With ECOG score 0-1.&#xD;
&#xD;
          2. Subjective aged 18-65 years, male or non-pregnant female.&#xD;
&#xD;
          3. Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated&#xD;
             or undifferentiated, i.e., the WHO type II or III).&#xD;
&#xD;
          4. Stage IVa (8th AJCC/UICC stage) T4 and/or N3, untreated patients with nasopharyngeal&#xD;
             carcinoma.&#xD;
&#xD;
          5. Agreeing to provide previously stored tumor tissue samples or perform biopsy to&#xD;
             collect tumor tissues, which were sent to the central laboratory for the PD-L1 IHC&#xD;
             test.&#xD;
&#xD;
          6. Hematology: white blood cells ≥ 4000 /μL; neutrophils ≥ 2000 /μL; hemoglobin ≥ 9 g/dL;&#xD;
             and platelets ≥ 100000 /μL.&#xD;
&#xD;
          7. Liver function: ALT and AST lower than the 1.5 times (1.5 × ) the upper limits of&#xD;
             normal (ULN); and total bilirubin &lt; 1.5 × ULN.&#xD;
&#xD;
          8. Renal function: serum creatinine &lt; 1.5 × ULN.&#xD;
&#xD;
          9. Patients signing the informed consents, and willing and able to follow the study plan&#xD;
             (visit and treatment plan), laboratory tests, and other research procedures.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.&#xD;
&#xD;
          2. Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification&#xD;
             type I).&#xD;
&#xD;
          3. Patients who had undergone radiotherapy or systemic chemotherapy.&#xD;
&#xD;
          4. Pregnant or breastfeeding females, or females in fertility period while with no&#xD;
             effective contraceptive measures.&#xD;
&#xD;
          5. Positive for HIV.&#xD;
&#xD;
          6. Having suffered from other malignant tumors (except for the cured basal cell carcinoma&#xD;
             or cervical carcinoma in situ).&#xD;
&#xD;
          7. Having been treated with inhibitors of immune regulatory points (i.e., CTLA-4, PD-1,&#xD;
             PD-L1, etc.).&#xD;
&#xD;
          8. With complications needing long-term application of immunosuppressive drugs, or&#xD;
             systemic or local application of corticosteroids with immunosuppressive doses of&#xD;
             comorbidities.&#xD;
&#xD;
          9. Patients with immunodeficiency diseases, or a history of organ transplantation&#xD;
             (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis,&#xD;
             pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; patients suffering&#xD;
             from vitiligo, or asthma in childhood completely relieved, with no need of any&#xD;
             intervention after adulthood could be included; and patients with asthma requiring&#xD;
             bronchodilators for medical intervention could not be included).&#xD;
&#xD;
         10. With excessive usage of glucocorticoids within 4 weeks.&#xD;
&#xD;
         11. Whose laboratory examination values that did not meet the relevant standards within 7&#xD;
             days before participating in the research.&#xD;
&#xD;
         12. Patients with markedly reduced heart, liver, lung, kidney and/or bone marrow&#xD;
             functions.&#xD;
&#xD;
         13. With serious and uncontrolled medical diseases and infections.&#xD;
&#xD;
         14. Using other test drugs or in other clinical trials.&#xD;
&#xD;
         15. Refusing or failing to sign the informed consent to participate in the trial.&#xD;
&#xD;
         16. With other treatment contraindications.&#xD;
&#xD;
         17. With personality or mental illness, with no or limited civil capacity.&#xD;
&#xD;
         18. Positive for hepatitis B surface antigen (HBsAg), and peripheral blood hepatitis B&#xD;
             virus deoxyribonucleic acid (HBV DNA) ≥ 1000 cps/mL.&#xD;
&#xD;
         19. Patients positive for the HCV antibody test could only be included in this study with&#xD;
             the negative results from the HCV RNA polymerase chain reaction test.&#xD;
&#xD;
         20. Unable to cooperate with regular follow-up due to psychological, social, family and&#xD;
             geographical reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>rensheng wang, Ph.D</last_name>
    <phone>86-771-5356509</phone>
    <email>13807806008@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>min kang, Ph.D</last_name>
    <phone>86-771-5356509</phone>
    <email>km1019@163.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Zhang S, Huang X, Zhou L, Wu G, Lin J, Yang S, Chen J, Lin S. An open-label, single-arm phase II clinical study of induction chemotherapy and sequential Nimotuzumab combined with concurrent chemoradiotherapy in N3M0 stage nasopharyngeal carcinoma. J BUON. 2018 Nov-Dec;23(6):1656-1661.</citation>
    <PMID>30610791</PMID>
  </reference>
  <reference>
    <citation>Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.</citation>
    <PMID>28837405</PMID>
  </reference>
  <reference>
    <citation>Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27. Erratum In: J Clin Oncol. 2018 Aug 1;36(22):2360.</citation>
    <PMID>29584545</PMID>
  </reference>
  <reference>
    <citation>Li Y, Tian Y, Jin F, Wu W, Long J, Ouyang J, Zhou Y. A phase II multicenter randomized controlled trial to compare standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy for the treatment of locally advanced nasopharyngeal carcinoma: Long-term outcomes update. Curr Probl Cancer. 2020 Feb;44(1):100492. doi: 10.1016/j.currproblcancer.2019.06.007. Epub 2019 Jul 2.</citation>
    <PMID>32035692</PMID>
  </reference>
  <reference>
    <citation>Kang M, Wang F, Liao X, Zhou P, Wang R. Intensity-modulated radiotherapy combined with endostar has similar efficacy but weaker acute adverse reactions than IMRT combined with chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma. Medicine (Baltimore). 2018 Jun;97(25):e11118. doi: 10.1097/MD.0000000000011118.</citation>
    <PMID>29924009</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Guangxi Medical University</investigator_affiliation>
    <investigator_full_name>min kang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endostar protein</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04447326
org study id: FirstGuangxiMU1
nct id: NCT04447326
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is to investigate the efficacy and safety of the induction chemotherapy +
      concurrent chemoradiotherapy（CCRT）combined with toripalimab and endostar treatment, in
      comparison with the induction chemotherapy + concurrent chemoradiotherapy（CCRT）, in treating
      locally advanced high-risk nasopharyngeal carcinoma
GP-induced chemotherapy combined with concurrent chemoradiotherapy is the standard treatment
      for the locally advanced nasopharyngeal carcinoma recommended by the guidelines. However, the
      prognosis for T4 and/or N3 nasopharyngeal carcinoma is still poor, with the 3-year PFS of
      about 70%. Therefore, it is of great importance to improve the prognosis of patients with
      locally advanced high-risk nasopharyngeal carcinoma. Immunotherapy has been an emerging
      treatment method for tumors in recent years. Compared with the chemotherapy, immunotherapy
      has less adverse reactions, and the effects could last longer, significantly improving the
      prognosis and patients' quality of life. Endostar, as a VEGFR inhibitor, has good safety in
      treating nasopharyngeal carcinoma. Related data have shown that PD-1 and Endostar exert
      synergistic antitumor effects in a mouse model of lung cancer. A Phase II multi-center
      clinical study from our center has shown that, for patients with locally advanced low-risk
      nasopharyngeal carcinoma, all the 3-year OS, PFS, and DMFS for the radiotherapy combined with
      Endostar group were superior to the concurrent chemoradiotherapy group, and the combination
      of radiotherapy and Endostar lead to significantly reduced adverse effects. In clinical
      studies concerning other solid tumors, it has also been observed that the PD-1 inhibitors
      combined with VEGFR inhibitors could significantly improve the efficacy, and achieve
      synergistic effects. Therefore, A Phase II，randomized, prospective, multicentric clinical
      trail was conducted to compare the efficacy and safety of induction chemotherapy and the
      concurrent chemoradiotherapy plus Endostar and PD-1, followed by PD-1 treatment for half a
      year compared with the induction chemotherapy and the concurrent chemoradiotherapy for the T4
      and/or N3 nasopharyngeal carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival, PFS
time frame: 3 years
description: calculated from the date of randomisation to the date of the documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. distant failure, or death from any cause, whichever occurred first.
measure: Overall Survival，OS
time frame: 3 years
description: the time from random assignment to death from any cause or censored at the date of last follow-up.
measure: locoregional relapse-free Survival, LRFS
time frame: 3 years
description: the time from random assignment to local or regional relapse.
measure: Distant metastasis-free survival,DMFS
time frame: 3 years
description: calculated from date of randomisation to the first distant failure
measure: Overall response rate (ORR)
time frame: 3 months
description: complete response (CR) + partial response (PR)
measure: adverse events (AEs) and severe adverse events (SAE)
time frame: 3 years
description: graded according to NCI CTCAE 5.0
arm group label: IC＋CCRT＋Toripalimab＋Endostar
arm group type: Experimental
description: Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w; Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles; Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles.
arm group label: IC＋CCRT
arm group type: Active Comparator
description: Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w.
intervention type: Drug
intervention name: Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy
description: Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles
arm group label: IC＋CCRT＋Toripalimab＋Endostar
other name: JS001
intervention type: Drug
intervention name: IC＋CCRT
description: IC＋CCRT
arm group label: IC＋CCRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: rensheng wang, Ph.D
phone: 86-771-5356509
email: 13807806008@163.com
last name: min kang, Ph.D
phone: 86-771-5356509
email: km1019@163.com
citation: Zhang S, Huang X, Zhou L, Wu G, Lin J, Yang S, Chen J, Lin S. An open-label, single-arm phase II clinical study of induction chemotherapy and sequential Nimotuzumab combined with concurrent chemoradiotherapy in N3M0 stage nasopharyngeal carcinoma. J BUON. 2018 Nov-Dec;23(6):1656-1661.
PMID: 30610791
citation: Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.
PMID: 28837405
citation: Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27. Erratum In: J Clin Oncol. 2018 Aug 1;36(22):2360.
PMID: 29584545
citation: Li Y, Tian Y, Jin F, Wu W, Long J, Ouyang J, Zhou Y. A phase II multicenter randomized controlled trial to compare standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy for the treatment of locally advanced nasopharyngeal carcinoma: Long-term outcomes update. Curr Probl Cancer. 2020 Feb;44(1):100492. doi: 10.1016/j.currproblcancer.2019.06.007. Epub 2019 Jul 2.
PMID: 32035692
citation: Kang M, Wang F, Liao X, Zhou P, Wang R. Intensity-modulated radiotherapy combined with endostar has similar efficacy but weaker acute adverse reactions than IMRT combined with chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma. Medicine (Baltimore). 2018 Jun;97(25):e11118. doi: 10.1097/MD.0000000000011118.
PMID: 29924009
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Guangxi Medical University
investigator full name: min kang
investigator title: professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Endostar protein