phase ii study for combination of camrelizumab and sbrt in the first-line treatment for r/m hnscc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the head and neck; 2. patients with untreated recurrent or metastatic disease; 3. combined positive score\>=1; 4. aged \>=18 years; 5. eastern cooperative oncology group (ecog) performance status 0-1; 6. at least one measurable lesion, according to recist 1.1; 7. major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): 1. hb\>=80g/l, anc\>=1.5x10\^9/l, plt \>=80x10\^9/l; 2. tbil\ =60ml/min; 3. 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); 4. bnp \<=uln; 5. t3 \<=uln and t4 \<=uln after treatment; 8. 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; 9. have signed consent form. exclusion criteria: 1. have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ; 2. known allergic reactions to the components of pd-1 monoclonal antibody; 3. central nervous system metastasis with symptoms; 4. treatment with a strong cyp3a4 inhibitor within 1 week or a strong inducer of cyp3a4 within 2 weeks. 5. congestive heart failure of new york heart association (nyha) class iii or iv; 6. ischemic cardiovascular events occurred within 1 year prior to the start of treatment; 7. ecg qt interval \>500ms; 8. patients are receiving immunosuppressive therapy; 9. treatment with an immunotherapy, including anti-pd-1, anti-pd-l1 and anti-ctla-4; 10. treatment with an investigational agent within 4 weeks; 11. treatment with oral or parenteral corticosteroids (\>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy; 12. treatment with anti-tumor vaccine or live vaccines within 4 weeks 13. surgery or severe trauma within 4 weeks; 14. active infection; 15. active autoimmune disease; 16. history of immunodeficiency, including hiv antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 17. history of noninfectious pneumonia; 18. active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment; 19. active hepatitis, including hbv dna ≥ 2000iu/ml or 10 ⁴ copies / ml or hcv antibody and hcv-rna positive; 20. history of alcoholism and drug abuse; 21. patients with symptoms of gastrointestinal bleeding or risk of bleeding; 22. patients are pregnant or breast-feeding; 23. any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.

Keywords: anti-pd-1 inhibitor stereotacic radiotherapy head and neck squamous cell carcinoma