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A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study

Primary Purpose

Head and Neck Cancer, Radiation, PD-1

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx
  2. With at least one high risk factor after radical surgery ①positive margin; ②close margin（<5mm); ③ENE.
  3. No distant metastases
  4. No synchronous or concurrent head and neck primary tumors
  5. ECOG PS 0-1
  6. Adequate organ function including the following:

Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 80 * 10^9/l Hemoglobin >= 80 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >30 ml/min 8. Signed written informed consent

Exclusion Criteria:

  1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  5. Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
  6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;

Sites / Locations

    Outcomes

    Primary Outcome Measures

    1-year disease free survival
    from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause

    Secondary Outcome Measures

    Overall survival
    from date of enrollment until death from any cause
    Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
    Acute toxicity profiles, graded according to the NCI CTCAE version 4.0

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 23, 2021
    Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04814069
    Brief Title
    A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
    Official Title
    A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
    To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Radiation, PD-1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab
    Intervention Description
    Tislelizumab 200mg q3w
    Primary Outcome Measure Information:
    Title
    1-year disease free survival
    Description
    from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    from date of enrollment until death from any cause
    Time Frame
    2 years
    Title
    Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
    Description
    Acute toxicity profiles, graded according to the NCI CTCAE version 4.0
    Time Frame
    up to 3 months after completion of radiotherapy

    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 squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx With at least one high risk factor after radical surgery ①positive margin; ②close margin（<5mm); ③ENE. No distant metastases No synchronous or concurrent head and neck primary tumors ECOG PS 0-1 Adequate organ function including the following: Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 80 * 10^9/l Hemoglobin >= 80 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >30 ml/min 8. Signed written informed consent Exclusion Criteria: Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;

    12. IPD Sharing Statement

    Learn more about this trial

    A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study

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