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Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT) (IMPORT)

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ClinicalTrials.gov Identifier: NCT04523883
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : April 15, 2021
Sponsor:
Collaborators:
Fudan University
Eye & ENT Hospital of Fudan University
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Fujian Medical University
Guizhou Provincial People's Hospital
Central South University
Information provided by (Responsible Party):
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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Brief Summary:
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: postoperative radiotherapy Drug: JS001 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 9, 2022
Estimated Study Completion Date : August 9, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: concurrent PD-1
Concurrent Immunotherapy With Postoperative Radiotherapy
 Radiation: postoperative radiotherapy
postoperative radiotherapy with a dose of 60-66Gy

Drug: JS001
JS001 240mg every three week
Other Name: Toripalimab
Active Comparator: Radiotherapy alone
Postoperative Radiotherapy alone
 Radiation: postoperative radiotherapy
postoperative radiotherapy with a dose of 60-66Gy


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from date of enrollment until death from any cause, assessed up to 2 years ]
  2. Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment [ Time Frame: up to 3 months after completion of radiotherapy ]
    Acute toxicity profiles, graded according to the NCI CTCAE version 4.0

  3. Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0 [ Time Frame: from 3 months after completion of radiotherapy up to 2 years ]
    Late toxicity profiles, graded according to the NCI CTCAE version 4.0


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

Inclusion Criteria:

  • 1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx) 2. With at least one risk factors after radical surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.

    3. Have at least one contraindication to cisplatin as defined:

    ① Age>65 years old; ②Creatinine clearance (CC) > 30 and < 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)* ((140-Age) / (Serum Creatinine)) * (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.

    4. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following:

    1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
    2. Platelets count >= 80 * 10^9/l
    3. Hemoglobin >= 80 g/dl
    4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
    5. Total bilirubin <= 1.5 times institutional ULN
    6. 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;
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): NCT04523883


Contacts
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Contact: Shengjin Dou 15800386875 doushengjin@126.com

Locations
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China
Guopei Zhu Recruiting
Shanghai, China, 200011
Contact: Shengjin Dou    15800386875    doushengjin@126.com   
Principal Investigator: Guopei Zhu         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Fudan University
Eye & ENT Hospital of Fudan University
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Fujian Medical University
Guizhou Provincial People's Hospital
Central South University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04523883    
Other Study ID Numbers: 2020HNRT03
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Head and neck cancer
radiotherapy
PD-1
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site