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Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tirelizumab
salvage surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Recurrent Nasopharyngeal Carcinoma, Tirelizumab, Immunotherapy, Endoscopic surgery, Survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed recurrent nasopharyngeal carcinoma
  2. The recurrence time is more than 6 months from the end of radiotherapy.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.
  5. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
  6. Given written informed consent.

Exclusion Criteria:

  1. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
  2. Has known subjects with other malignant tumors.
  3. Has participated in other drug trials within 3 months of planned start of study treatment.
  4. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
  5. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
  6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
  7. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
  8. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
  9. Has received a live vaccine within 4 weeks of planned start of study treatment.
  10. Pregnancy or breast feeding.
  11. Cannot complete regular follow-up.
  12. Local recurrence of nasopharyngeal carcinoma with distant metastasis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tirelizumab plus salvage surgery

    salvage surgery alone

    Arm Description

    Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

    Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

    Outcomes

    Primary Outcome Measures

    Progress-free survival(PFS)
    Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause

    Secondary Outcome Measures

    Overall survival(OS)
    Defined as the time interval from randomization to death due to any cause.
    Locoregional failure-free survival(LRRFS)
    The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
    Distant metastasis-free survival(DMFS)
    The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
    Incidence of treatment related complications
    Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up

    Full Information

    First Posted
    October 12, 2021
    Last Updated
    October 22, 2021
    Sponsor
    Eye & ENT Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05092217
    Brief Title
    Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
    Official Title
    Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2021 (Anticipated)
    Primary Completion Date
    October 20, 2023 (Anticipated)
    Study Completion Date
    October 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eye & ENT Hospital of Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma
    Keywords
    Recurrent Nasopharyngeal Carcinoma, Tirelizumab, Immunotherapy, Endoscopic surgery, Survival

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tirelizumab plus salvage surgery
    Arm Type
    Experimental
    Arm Description
    Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
    Arm Title
    salvage surgery alone
    Arm Type
    Active Comparator
    Arm Description
    Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
    Intervention Type
    Drug
    Intervention Name(s)
    Tirelizumab
    Other Intervention Name(s)
    PD-1 antibody
    Intervention Description
    Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
    Intervention Type
    Procedure
    Intervention Name(s)
    salvage surgery
    Intervention Description
    Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
    Primary Outcome Measure Information:
    Title
    Progress-free survival(PFS)
    Description
    Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Overall survival(OS)
    Description
    Defined as the time interval from randomization to death due to any cause.
    Time Frame
    2 years
    Title
    Locoregional failure-free survival(LRRFS)
    Description
    The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
    Time Frame
    2 years
    Title
    Distant metastasis-free survival(DMFS)
    Description
    The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
    Time Frame
    2 years
    Title
    Incidence of treatment related complications
    Description
    Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed recurrent nasopharyngeal carcinoma The recurrence time is more than 6 months from the end of radiotherapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. Given written informed consent. Exclusion Criteria: Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness. Has known subjects with other malignant tumors. Has participated in other drug trials within 3 months of planned start of study treatment. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive. Has received a live vaccine within 4 weeks of planned start of study treatment. Pregnancy or breast feeding. Cannot complete regular follow-up. Local recurrence of nasopharyngeal carcinoma with distant metastasis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wanpeng Li, MD
    Phone
    13262856870
    Email
    18879117831@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Hu, MD
    Phone
    18917786049
    Email
    hl318ent@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

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