a study of si-b001+si-b003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this study is a open, multi-center phase ii clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of si-b001+si-b003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. patients with recurrent or metastatic head and neck squamous cell carcinoma; 6. consent to provide tumor tissue samples or fresh tissue samples archived from the primary or metastatic lesions within 2 years; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. physical status score: ecog ≤1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. no blood transfusion or colony-stimulating factor was allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements; 12. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤1.5×uln; 13. urinary protein ≤1+ or ≤1000mg/24h; 14. fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose. exclusion criteria: 1. squamous cell carcinoma of the nasopharynx, salivary gland, paranasal sinus, skin or of unknown primary site; 2. patients with any of the following conditions were not eligible for the study: a) suitable and willing for local treatment; b) received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy; 3. patients with active central nervous system metastasis; 4. who had participated in any other clinical trial within 4 weeks before the study dose; 5. received radiotherapy within 4 weeks before the first dose of study drug; 6. use of traditional chinese medicine with anti-tumor indications within 2 weeks; 7. had undergone major surgery within 4 weeks before the first dose; 8. systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing; 9. pulmonary disease was defined as ≥ grade 3 according to nci-ctcae v5.0; patients with existing or a history of interstitial lung disease (ild); 10. have active infection requiring intravenous anti-infective therapy; 11. had received immunotherapy and had grade ≥3 irae or grade ≥2 immune-related myocarditis; 12. received live attenuated vaccine within 4 weeks before the first dose of study drug; 13. had taken an immunomodulatory drug within 14 days before the first dose of study drug; 14. patients at risk for active autoimmune disease or with a history of autoimmune disease; 15. other malignant tumors within 5 years before the first administration; 16. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or hepatitis c virus infection; 17. poorly controlled hypertension; 18. patients with poor blood glucose control before the first dose; 19. had a history of severe cardiovascular and cerebrovascular diseases; 20. previous history of allogeneic stem cell, bone marrow or organ transplantation; 21. patients with massive or symptomatic effusions or poorly controlled effusions; 22. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of si-b001 or si-b003; 23. had severe infusion reactions to antibody therapy in the past; 24. had autologous or allogeneic stem cell transplantation; 25. pregnant or lactating women; 26. the investigator did not consider it appropriate to apply other criteria for participation in the trial.