Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC

Study Overview
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Brief Summary
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This study is a prospective, single-center, open-label, phase II clinical study for patients with recurrent or metastatics quamous cell carcinoma of the head and neck.

Official Title
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Phase II Study for Combination of Camrelizumab and Stereotacic Radiotherapy in the First-line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Camrelizumab and SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck; Patients with untreated recurrent or metastatic disease; Combined positive Score>=1; Aged >=18 years; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; At least one measurable lesion, according to RECIST 1.1; Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): HB>=80g/L, ANC>=1.5x10^9/L, PLT >=80x10^9/L; TBIL<=1.5 ULN, ALT and AST <=2.5 ULN, if there exists hepatic metastases, ALT and AST <=5 ULN, Cr <=1.5 ULN or CCr >=60ml/min; INR or PT <= 1.5 ULN, APTT <=1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range); BNP <=ULN; T3 <=ULN and T4 <=ULN after treatment; Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment; For female subjects with reproductive potential: a negative serum pregnancy test; Have signed consent form. Exclusion Criteria: Have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ; Known allergic reactions to the components of PD-1 monoclonal antibody; Central nervous system metastasis with symptoms; Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4 within 2 weeks. Congestive heart failure of New York Heart Association (NYHA) Class III or IV; Ischemic cardiovascular events occurred within 1 year prior to the start of treatment; ECG QT interval >500ms; Patients are receiving immunosuppressive therapy; Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4; Treatment with an investigational agent within 4 weeks; Treatment with oral or parenteral corticosteroids (>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy; Treatment with anti-tumor vaccine or live vaccines within 4 weeks Surgery or severe trauma within 4 weeks; Active infection; Active autoimmune disease; History of immunodeficiency, including HIV antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; History of noninfectious pneumonia; Active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment; Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody and HCV-RNA positive; History of alcoholism and drug abuse; Patients with symptoms of gastrointestinal bleeding or risk of bleeding; Patients are pregnant or breast-feeding; Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Combination of camrelizumab and stereotacic radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Other: Camrelizumab and SBRT<br>* Camrelizumab: 200mg every 3 weeks; SBRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-Free-Survival | up to approximately 2 years | 
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to approximately 2 years | 
| DOR | Disease Control Rate | up to approximately 2 years | 
| AE | Adverse Events | from the first drug administration to within 30 days for the last therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-PD-1 Inhibitor, Stereotacic Radiotherapy, Head and Neck Squamous Cell Carcinoma