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Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04624308
Recruitment Status : Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Sun Yan, Peking University

Study Description
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Brief Summary:
TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival.

Condition or disease Intervention/treatment Phase
Hypopharyngeal Neoplasm Malignant Primary Drug: Toripalimab Phase 2

Detailed Description:
Inductive chemotherapy plus CCRT or operation is an option of organ preservation for patients of hypopharyngeal carcinoma. Many clinical studies have demonstrated that inductive chemotherapy plus CCRT achieved the same prognosis as total laryngectomy, and minimized the damage of normal tissue. TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival. This is a prospective, phase II, cohort study. We designate TPF plus Toripalimab as the inductive regime, expecting a higher complete remission rate and longer PFS and OS. And we replace the CCRT with radiation plus Toripalimab to decrease the adverse events of CCRT.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Toripalimab Plus TPF Inductive Chemotherapy and Definitive Radiotherapy for Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Efficacy and Safety: a Phase II Prospective Cohort Study
Estimated Study Start Date : October 30, 2020
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab
TPF inductive chemotherapy plus Toripalimab for 3 cycles, and radiotherapy plus Toripalimab if the inductive treatment efficacy is CR or >75%PR. If not, operation is suggested.
 Drug: Toripalimab
Toripalimab 240mg d1，Q3W. Given with TPF during inductive chemotherapy and definitive radiotherapy.
Other Name: Tuoyi


Outcome Measures
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Primary Outcome Measures :
  1. Complete remission rate [ Time Frame: 3 months after treatment ]
    Complete remission rate 3 months after treatment


Secondary Outcome Measures :
  1. ORR [ Time Frame: 3 months after treatment ]
    objective response rate

  2. DCR [ Time Frame: 5 year ]
    disease control rate

  3. PFS [ Time Frame: 5 year ]
    progression free survival

  4. OS [ Time Frame: 5 year ]
    overall survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18y ≤age≤65y;
  2. ECOG：0-1；
  3. Histology：squamous cell carcinoma, located in hypopharynx;
  4. clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
  5. never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
  6. at least one measurable lesion (RECIST 1.1 criteria).
  7. expected survival ≥6 months.
  8. no contraindications of radiotherapy, chemotherapy and immune therapy.
  9. functions of main organs A. WBC≥3.0x109 /L，ANC≥1.5x109/L B. HB≥90g/L C. PLT≥100x109 /L D. serum albumin≥2.8g/dL E. TBil ≤1.5xULN，ALT、AST≤3.0xULN F. serum creatinine ≤1.5xULN or creatinine clearance rate>60mL/min（Cockcroft-Gault） G. APTT and INR ≤1.5xULN
  10. contraception
  11. voluntary and compliance.

Exclusion Criteria:

  1. other histology cancers located in hypopharynx.
  2. synchronous or metachronous cancers located in other sites.
  3. allergy to monoclonal antibody.
  4. uncontrollable heart disease or symptoms.
  5. uncontrollable infections.
  6. fever of unknown origin>38.5℃ during screening or before administration.
  7. active autoimmune disease.
  8. history of immunodeficiency disorders, including HIV.
  9. active HBV or HCV.
  10. history of interstitial lung disease.
  11. active tuberculosis.

  12. received any drugs listed below: A. received any study drug 4 weeks before first dose of Toripalimab. B. received any anti-cancer drug 4 weeks before first dose of Toripalimab. C. received any glucocorticoids （>10mg prednison per day） 2 weeks before first dose of Toripalimab.

    D. received any cancer vaccine 4 weeks before first dose of Toripalimab. E. received any operation or trauma 4 weeks before first dose of Toripalimab. F. recruited in other study.

  13. uncontrollable hypertension.
  14. uncontrollable type 2 diabetes；
  15. hemorrhagic tendency.
  16. drug or alcoholic abuse.
  17. woman during pregnancy or lactation period.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624308


Contacts
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Contact: Yan Sun, MD 0086-10-88196217 lisaysun@139.com

Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Contact: Yan Sun, MD    010-88196217    lisaysun@139.com   
Sponsors and Collaborators
Sun Yan
Shanghai Junshi Bioscience Co., Ltd.
Investigators
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Principal Investigator: Yan Sun, MD Beijing Cancer Hospital
More Information
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Responsible Party: Sun Yan, Principal Investigator, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University, Peking University
ClinicalTrials.gov Identifier: NCT04624308    
Other Study ID Numbers: 2020-JS001-HPSCC
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is administered by Peking University Cancer Hospital, the investigators need to request related department for sharing IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yan, Peking University:
hypopharyngeal carcinoma
radiotherapy
inductive chemotherapy
PD-1 inhibitor
Additional relevant MeSH terms:
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Neoplasms
Hypopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases