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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HNSCC
• Intervention / Treatment: Drug: Camrelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junlin Yi; Phone Number: 13661217998; Email: yijunlin1969@163.com
• Study Contact Backup: Name: Ye Zhang; Phone Number: 010-87787625; Email: drzye1983@163.com

Study Locations

• China
  • Beijing, China, 100021
    • Cancer hospital, Chineses Academy of Medical Sciences
    • Contact: Junlin Yi, M.D.; Phone Number: 13661217998; Email: yijunlin1969@163.com
    • Principal Investigator: Junlin Yi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year progression-free survival rate		1 year from the the date of randomization
overall survival	OS is the time from randomization to death due to any cause.	Up to 3 years
objective response rate		Up to 3 years
disease control rate		Up to 3 years
time to progression		Up to 3 years
progression-free survival(in accordance with irRECIST1.1)		Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
event-free survival in exploration group	EFS is the time from the date of randomization to any event	Up to 3 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Junlin Yi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): July 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Chemoradiation; Immunotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CATCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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