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Camrelizumab as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

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: NCT04861467
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Jun-Lin Yi, MD, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.

Condition or disease Intervention/treatment Phase
HNSCC Drug: Camrelizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Study of Camrelizumab vs Placebo as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Camrelizumab
camrelizumab as maintenance therapy after Chemoradiation(evaluation results：PR/SD)
 Drug: Camrelizumab
IV
No Intervention: observation
observation after Chemoradiation
Experimental: Exploration：Camrelizumab
camrelizumab for maintenance after chemoradiation( evaluation results：CR)
 Drug: Camrelizumab
IV


Outcome Measures
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Primary Outcome Measures :
  1. median progression-free survival(in accordance with RECIST1.1) [ Time Frame: Up to 3 years ]
    mPFS is the median time from the date of randomization to the date of first record of disease progression or death.


Secondary Outcome Measures :
  1. 1 year progression-free survival rate [ Time Frame: 1 year from the the date of randomization ]
  2. overall survival [ Time Frame: Up to 3 years ]
    OS is the time from randomization to death due to any cause.

  3. objective response rate [ Time Frame: Up to 3 years ]
  4. disease control rate [ Time Frame: Up to 3 years ]
  5. time to progression [ Time Frame: Up to 3 years ]
  6. progression-free survival(in accordance with irRECIST1.1) [ Time Frame: Up to 3 years ]

Other Outcome Measures:
  1. event-free survival in exploration group [ Time Frame: Up to 3 years ]
    EFS is the time from the date of randomization to any event


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Who have histologic or cytologic confirmation of head and neck squamous cell carcinoma in the mouth, oropharynx (p16-), hypopharynx, or larynx.
  • Local advanced head and neck squamous cell carcinoma diagnosed as stage III-IVa by AJCC 8
  • Except for the prescribed radical radiotherapy and chemotherapy regimen, there has been no previous treatment for LA-HNSCC systemic antitumor or local radical therapy (allowing the prescribed induction chemotherapy regimen before radical radiotherapy and chemotherapy)
  • 28 days after radical radiotherapy and chemotherapy (radiotherapy and chemotherapy (±7 days) did not show disease progression, and consideration was given within 28 days after curative effect evaluation
  • Clinically assessable lesions according to RECIST1.1,(lesion length ≥10 mm or lymph node short diameter ≥15 mm)
  • The age at which informed consent is signed is 18-70 years, male and female
  • KPS score ≥80 percent
  • Estimated lifetime ≥6 months
  • The function of important organs meets the following requirements (excluding the use of any blood components and cytokines within 14 days):

Normal bone marrow reserve function: WBC≥3.0×10^9/ L, NEUT≥1.5×10^9/ L, PLT≥80×10^9/ L, Hb≥90g/L Normal renal function or SCr≤1.5 times normal upper limit (ULN) or Ccr≥50 ml/min ; Normal liver function or TBIL≤1.5 times the upper limit of normal value (ULN); AST or ALT level 2.5 times the upper limit of normal value (ULN);

  • Ability and willingness to follow research and follow-up procedures
  • Men and women of childbearing age must agree to adequate contraception throughout the study period and within 6 months after treatment
  • The subjects volunteered to join the clinical study and signed informed consent, good compliance and follow-up

Exclusion Criteria:

  • 1.Have received any systemic anti-tumor therapy against the target lesion
  • Previous experience in head and neck radiotherapy
  • Previous immunotherapies including anti PD-1/PD-L1, anti CTLA-4, etc
  • Subjects who received anti-tumor vaccines or other immunomodulatory drugs (e.g. interleukin-2, thymosin, Lentinus edodes polysaccharide, etc.) within 1 month prior to joining the group, or who received live attenuated vaccines
  • Subjects who had been systematically treated with corticosteroids (prednisone or other equivalent hormones >10 mg/ days) or other immunosuppressants within 1 month of entry. To allow inhaled or local use of corticosteroids in the absence of active autoimmune disease, as well as adrenocorticotropic replacement therapy ≤10 days mg/ dose of prednisone
  • Pleural effusions, pericardial effusions or ascites requiring drainage, or serosal effusions for treatment within 2 weeks prior to group entry
  • No active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary, vasculitis, nephritis, hyperthyroidism, hypothyroidism) may be included
  • Subjects with severe infection within 1 month prior to admission, including, but not limited to, infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection, or unexplained fever >38.5℃ during screening, prior to first administration
  • Severe cardiovascular disease: grade II myocardial ischemia or myocardial infarction, uncontrolled arrhythmia; grade III ~ IV cardiac insufficiency, or echocardiography indicated that left ventricular ejection fraction (LVEF)<50%;
  • The subjects were treated with bronchiectasis and other systemic treatments. Asthma control was unsatisfactory and could not be included (asthma was completely alleviated in childhood and included without any intervention in adults)
  • HIV infection or known AIDS, active hepatitis B (HBV DNA≥500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
  • Subjects with a history of other malignancies within five years (except complete treatment of skin cancer with cervical or basal cell carcinoma or squamous cell carcinoma in situ)
  • Patients with a clear history of allergies may be allergic to, or intolerant to Camrelizumab
  • Persons with a history of substance abuse and who are unable to abstain or who have mental disorders Increasing the risk associated with participating in a study or research drug and, according to the researcher's judgment, other circumstances in which the subjects are not suitable for inclusion in the study
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): NCT04861467


Contacts
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Contact: Junlin Yi 13661217998 yijunlin1969@163.com
Contact: Ye Zhang 010-87787625 drzye1983@163.com

Locations
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China
Cancer hospital, Chineses Academy of Medical Sciences
Beijing, China, 100021
Contact: Junlin Yi, M.D.    13661217998    yijunlin1969@163.com   
Principal Investigator: Junlin Yi, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Junlin Yi Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Jun-Lin Yi, MD, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04861467    
Other Study ID Numbers: CATCH
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: March 2021
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jun-Lin Yi, MD, Chinese Academy of Medical Sciences:
Immunotherapy
Chemoradiation
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site