<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/NCT03820596</url>
  </required_header>
  <id_info>
    <org_study_id>SCENT</org_study_id>
    <nct_id>NCT03820596</nct_id>
  </id_info>
  <brief_title>Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL</brief_title>
  <official_title>Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Refractory and Relapsed Extranodal Natural Killer Cell/T-cell Lymphoma(EN): A Single-arm, Multicenter Phase I b/II Study(SCENT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huiqiang Huang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extranodal natural killer/T cell lymphoma(ENKTCL) is a distinct lymphoid neoplasm with&#xD;
      aggressive course and poor outcomes. Optimal treatment strategies for advanced ENKTCL have&#xD;
      not been fully defined.Patients with disseminated or relapsed disease have a very poor&#xD;
      outcome,and there is no standard management for relapsed or refractory disease.Combination&#xD;
      chemotherapy remains the mainstay of treatment.In small retrospective studies have observed&#xD;
      very good response and survival rates in patients treated with L-asparaginase.In several&#xD;
      prospective study that examined relapsed/refractory patients treated with SMILE outside a&#xD;
      trial setting,the efficacy sounds good. But treatment related mortality was 7%. The regimen&#xD;
      has toxicity, with careful attention to adverse effects and skill acquired through&#xD;
      experience. Chidamide, a oral subtype-selective histone deacetylase inhibitor monotherapy was&#xD;
      effective on the patients with relapsed or refractory ENKTCL in our study. Objective response&#xD;
      rate was 50.0% (6/12) with complete response(CR) rate 33.3 %( 4/12).All four CR patients were&#xD;
      still in disease-free more than 6.9 months (6.9-10.5). ENKTCL are invariably infected by&#xD;
      Epstein-Barr virus(EBV).EBV-infected lymphoma cells upregulate programmed death ligand 1&#xD;
      (PDL1), ligand of the inhibitory receptor programmed death 1(PD1) on T cells.Ligation of PDL1&#xD;
      on lymphoma cells with PD1 on effector T cells suppresses T-cell cytotoxicity. The PDL1/PD1&#xD;
      axis is therefore a potential mechanism for ENKTCL to avert effector T-cell targeting.PD1&#xD;
      blockadewith pembrolizumab was a potent strategy for ENKTCL failing L-asparaginase regimens&#xD;
      in several reports.We carried out a single, open-label, multicenter clinical trial enrolled&#xD;
      patients with relapsed or refractory ENKTCL to safety and efficacy of sintilimab in&#xD;
      combination With chidamide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <phase>Phase 1/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>Phase 1 Study: Percentage of Participants Experiencing Adverse Events defined as Dose Limiting Toxicities (DLTs) of Chidamide.</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Dose-limiting toxicity is defined as protocol-defined chidamide related events within the first 90 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1 Study: Maximum tolerable dose of chidamide among participants</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Maximum tolerable dose is defined as protocol-defined the highest quantity chidamide among participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1 Study: Maximum tolerable dose(MTD) and recommended Phase 2 dose (RP2D) of chidamide among participants</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Maximum tolerable dose is defined as protocol-defined the highest quantity chidamide among participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2 Safety Management Study</measure>
    <time_frame>Up to12 months</time_frame>
    <description>Incidence and Severity of Toxicities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of sintilimab plus chidamide in refractory and relapsed ENKTCL</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective response including CR and PR rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to12 months</time_frame>
    <description>PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to12 months</time_frame>
    <description>Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or Among participants who experience an objective response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>OS is defined as the time from treatment to the date of death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Safety and Efficacy</condition>
  <arm_group>
    <arm_group_label>Sintilimab+Chidamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sintilimab：200mg(fixed dosage), ivd, qd, q21d&#xD;
Chidamide:&#xD;
Phase I: 20mg-30mg,biw,continued oral，to evaluate RP2D. Phase II：RP2D，continued oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sintilimab</intervention_name>
    <description>To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.&#xD;
To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects.</description>
    <arm_group_label>Sintilimab+Chidamide</arm_group_label>
    <other_name>Tyvyt®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.&#xD;
To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects.</description>
    <arm_group_label>Sintilimab+Chidamide</arm_group_label>
    <other_name>Epidaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Volunteer to participate in clinical research; fully understand and know the research&#xD;
             and sign the Informed Consent Form (ICF); willing to follow and have the ability to&#xD;
             complete all trial procedures;&#xD;
&#xD;
          2. Aged 18-75 years old male or female;&#xD;
&#xD;
          3. Extranodal NK/T-cell lymphoma confirmed by histopathology examination;&#xD;
&#xD;
          4. Paraffin tissue specimens or fresh puncture tissue specimens are available;&#xD;
&#xD;
          5. Patients with disease progression or non-remission after asparaginase treatment or&#xD;
             asparaginase-contained regimen treatment. Non-remission is defined as: patients did&#xD;
             not get partial remission (PR) or better responses after treated by L-asparaginase&#xD;
             contained regimen;&#xD;
&#xD;
          6. Eastern cooperative oncology group score: 0-1;&#xD;
&#xD;
          7. Estimated survival ≥ 3 months;&#xD;
&#xD;
          8. There must be at least one evaluate able or measurable lesion that meets the RECIL&#xD;
             2017 Lymphoma criteria [evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission&#xD;
             Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake&#xD;
             (higher than liver) and PET and/or computed tomography (Computed Tomography) CT)&#xD;
             features are consistent with lymphoma findings; lesions can be measured: nodular&#xD;
             lesions &gt; 15mm or extranodal lesions &gt; 10mm (if the only measurable lesion has&#xD;
             received radiotherapy in the past, there must be evidence of radiological progress&#xD;
             after radiotherapy), and accompanied by increased 18FDG uptake). Except for this,&#xD;
             there is no measurable increase in diffuse 18FDG uptake in the liver;&#xD;
&#xD;
          9. Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac,&#xD;
             pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood&#xD;
             transfusion, granulocyte colony stimulating factor or other medical support was&#xD;
             received within 14 days prior to the use of the research drug): 1) The absolute value&#xD;
             of neutrophils (&gt;1.0×10^9/L); 2) platelet count (&gt; 75×10^9/L); 3) Hemoglobin (&gt; 9&#xD;
             g/dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (&gt;40 mL/min) of serum&#xD;
             creatinine (&lt;1.5 times normal value upper limit) (estimated by Cockcroft-Gault&#xD;
             formula); 5) Serum total bilirubin &lt; 1.5 times ULN; 6) Aspartate Aminotransferase&#xD;
             (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function:&#xD;
             International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated&#xD;
             Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving&#xD;
             anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening&#xD;
             time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free&#xD;
             triiodothyronine (FT3) were all within the normal range (+10%);&#xD;
&#xD;
         10. There was no evidence that subjects had difficulty breathing at rest, and the measured&#xD;
             value of pulse oximetry at rest was more than 92%;&#xD;
&#xD;
         11. Participants must pass a pulmonary function test (PFT) to confirm that forced&#xD;
             expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is more than&#xD;
             60%, unless it is a large mediastinal mass caused by lymphoma that cannot meet this&#xD;
             standard; carbon monoxide diffusion (DLCO), FEV1 and FVC are all above 50% of the&#xD;
             predicted value; all PFT results must be obtained within four weeks before the first&#xD;
             administration;&#xD;
&#xD;
         12. Subjects who have received antineoplastic therapy should be admitted to the group only&#xD;
             after the toxicity of the previous treatment has returned to the level of Common&#xD;
             Terminology Criteria for Adverse Events (CTCAE) V5.0 grade score &lt; 1 or baseline&#xD;
             level; the level 2 toxicity caused by previous antineoplastic treatment is&#xD;
             irreversible and is not expected to deteriorate during the study period. (e.g.&#xD;
             thrombocytopenia, anemia, neurotoxicity, alopecia and hearing loss) can be enrolled&#xD;
             with the consent of the researchers;&#xD;
&#xD;
         13. Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within&#xD;
             seven days before the first medication and the results are negative. WOBCP or men and&#xD;
             their WOBCP partners should agree to take effective contraceptive measures from the&#xD;
             signing of ICF until six months after the last dose of the research drug is used&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Invasive natural killer cell leukemia; 2. Hemophagocytic syndrome; 3. Primary central&#xD;
        nervous system lymphoma or secondary central nervous system involvement; 4. Received organ&#xD;
        transplantation in the past; 5. Patients who received allogeneic hematopoietic stem cell&#xD;
        transplantation within three years before the drug was given (patients who received&#xD;
        allogeneic hematopoietic stem cell transplantation more than three years before the drug&#xD;
        was given and who currently have no graft-versus-host response can be enrolled); 6.&#xD;
        Participating in other clinical studies or planning to start this study is less than 4&#xD;
        weeks from the end of the previous clinical study; 7. Autologous hematopoietic stem cell&#xD;
        transplantation was performed within 90 days before the start of the study; 8. The drug was&#xD;
        treated with histone deacetylase inhibitors within one year before administration; 9.&#xD;
        Patients with active autoimmune diseases requiring systematic treatment in the past two&#xD;
        years (hormone replacement therapy is not considered systematic treatment, such as type I&#xD;
        diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy,&#xD;
        adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of&#xD;
        glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require&#xD;
        systematic treatment within two years can be enrolled; 10. Begin the study on subjects&#xD;
        requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given&#xD;
        condition within 14 days before treatment [allowing subjects to use local, ocular,&#xD;
        intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic&#xD;
        absorption); and allowing short-term (&lt; 7 days) glucocorticoid prophylaxis (e.g., contrast&#xD;
        agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed&#xD;
        hypersensitivity caused by contact allergens); 11. In the past five years, patients with&#xD;
        other malignant tumors have undergone radical treatment, except for basal cell carcinoma of&#xD;
        skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of&#xD;
        cervix.&#xD;
&#xD;
        12. Begin the study and receive systemic antineoplastic therapy within 28 days before&#xD;
        treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or&#xD;
        growth factors that control cancer), etc.; 13. The study began with major surgery within 28&#xD;
        days before treatment or radiotherapy within 90 days before treatment; 14. Start the study&#xD;
        and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days&#xD;
        before treatment; 15. Begin research on live vaccination (except influenza attenuated&#xD;
        vaccine) within 28 days before treatment; 16. History of human immunodeficiency virus (HIV)&#xD;
        infection and/or patients with acquired immunodeficiency syndrome are known; 17. Patients&#xD;
        with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B&#xD;
        Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass&#xD;
        further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 500&#xD;
        IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In&#xD;
        addition to active hepatitis B or hepatitis C infections requiring treatment, group trials&#xD;
        can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher&#xD;
        than 2500 copies/mL or 500 IU/mL) after drug treatment, and cured hepatitis C patients can&#xD;
        be enrolled in the group; 18. Patients with active pulmonary tuberculosis; 19. Start&#xD;
        studying any active infections requiring systemic anti-infective treatment within 14 days&#xD;
        of treatment.&#xD;
&#xD;
        20. Pregnant or lactating women; 21. People with known history of alcoholism or drug abuse;&#xD;
        22. Have uncontrollable complications, including but not limited to symptomatic congestive&#xD;
        heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or&#xD;
        hemorrhagic diseases; 23. History of interstitial lung disease or non-infectious pneumonia.&#xD;
        Subjects who had previously had non-infectious pneumonia caused by drugs or radiation but&#xD;
        had no symptoms were allowed to enter the group; 24. The QTcF interval is more than 450&#xD;
        msec, unless it is secondary to bundle branch block; 25. Past psychiatric history;&#xD;
        incapacitated or restricted; 26. According to the researchers'judgment, patients'&#xD;
        underlying condition may increase their risk of receiving research drug treatment, or&#xD;
        confuse their judgment on toxic reactions; 27. Other researchers consider it unsuitable for&#xD;
        patients to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of hematology department, Nanfang hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital; Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Huiqiang Huang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Sintilimab</keyword>
  <keyword>Chidamide</keyword>
  <keyword>refractory and relapsed</keyword>
  <keyword>Extranodal natural killer cell/T-cell lymphoma</keyword>
  <!-- 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/NCT03820596
org study id: SCENT
nct id: NCT03820596
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Extranodal natural killer/T cell lymphoma(ENKTCL) is a distinct lymphoid neoplasm with
      aggressive course and poor outcomes. Optimal treatment strategies for advanced ENKTCL have
      not been fully defined.Patients with disseminated or relapsed disease have a very poor
      outcome,and there is no standard management for relapsed or refractory disease.Combination
      chemotherapy remains the mainstay of treatment.In small retrospective studies have observed
      very good response and survival rates in patients treated with L-asparaginase.In several
      prospective study that examined relapsed/refractory patients treated with SMILE outside a
      trial setting,the efficacy sounds good. But treatment related mortality was 7%. The regimen
      has toxicity, with careful attention to adverse effects and skill acquired through
      experience. Chidamide, a oral subtype-selective histone deacetylase inhibitor monotherapy was
      effective on the patients with relapsed or refractory ENKTCL in our study. Objective response
      rate was 50.0% (6/12) with complete response(CR) rate 33.3 %( 4/12).All four CR patients were
      still in disease-free more than 6.9 months (6.9-10.5). ENKTCL are invariably infected by
      Epstein-Barr virus(EBV).EBV-infected lymphoma cells upregulate programmed death ligand 1
      (PDL1), ligand of the inhibitory receptor programmed death 1(PD1) on T cells.Ligation of PDL1
      on lymphoma cells with PD1 on effector T cells suppresses T-cell cytotoxicity. The PDL1/PD1
      axis is therefore a potential mechanism for ENKTCL to avert effector T-cell targeting.PD1
      blockadewith pembrolizumab was a potent strategy for ENKTCL failing L-asparaginase regimens
      in several reports.We carried out a single, open-label, multicenter clinical trial enrolled
      patients with relapsed or refractory ENKTCL to safety and efficacy of sintilimab in
      combination With chidamide.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1 Study: Percentage of Participants Experiencing Adverse Events defined as Dose Limiting Toxicities (DLTs) of Chidamide.
time frame: Up to 90 days
description: Dose-limiting toxicity is defined as protocol-defined chidamide related events within the first 90 days
measure: Phase 1 Study: Maximum tolerable dose of chidamide among participants
time frame: Up to 90 days
description: Maximum tolerable dose is defined as protocol-defined the highest quantity chidamide among participants.
measure: Phase 1 Study: Maximum tolerable dose(MTD) and recommended Phase 2 dose (RP2D) of chidamide among participants
time frame: Up to 90 days
description: Maximum tolerable dose is defined as protocol-defined the highest quantity chidamide among participants.
measure: Phase 2 Safety Management Study
time frame: Up to12 months
description: Incidence and Severity of Toxicities
measure: Efficacy of sintilimab plus chidamide in refractory and relapsed ENKTCL
time frame: Up to 24 months
description: Objective response including CR and PR rate
measure: Progression-Free Survival (PFS)
time frame: Up to12 months
description: PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.
measure: Duration of Response (DOR)
time frame: Up to12 months
description: Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or Among participants who experience an objective response.
measure: Overall Survival (OS)
time frame: Up to 24 months
description: OS is defined as the time from treatment to the date of death.
arm group label: Sintilimab+Chidamide
arm group type: Experimental
description: Sintilimab：200mg(fixed dosage), ivd, qd, q21d
Chidamide:
Phase I: 20mg-30mg,biw,continued oral，to evaluate RP2D. Phase II：RP2D，continued oral
intervention type: Drug
intervention name: Sintilimab
description: To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.
To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects.
arm group label: Sintilimab+Chidamide
other name: Tyvyt®
intervention type: Drug
intervention name: Chidamide
description: To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.
To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects.
arm group label: Sintilimab+Chidamide
other name: Epidaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Huiqiang Huang
investigator title: professor