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

Condition	Head and Neck Squamous Cell Carcinoma
Age	18years - 100years
Treatment	Camrelizumab and SBRT
Clinical Study Identifier	NCT04399785
Sponsor	Xingchen Peng
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 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

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

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