recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses
Conditions
Interventions
experimental group:pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel)
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign a written informed consent form before screening; 2) Age 18 to 75 years old; 3) ECOG performance status score 0-1 points; 4) Squamous cell carcinoma of the nasal cavity and paranasal sinuses confirmed by histology or cytology; 5) Recurrent and/or metastatic lesions without local curative treatment indications; 6) According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one measurable lesion. For lesions that have received radiotherapy in the past, only if there is definite disease progression 3 months after the end of radiotherapy, can they be selected as target lesions; 7) There are sufficient tumor tissue samples for PD-L1 immunohistochemical detection; 8) The expected survival period exceeds 3 months; 9) The main organs function normally, that is, the following criteria are met: i. Blood routine (no blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) therapy within 14 days prior to the screening examination) : Neutrophils=1.5×109/L, Platelets=100×109/L, Hemoglobin=90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST=3×ULN for those without liver metastases, ALT and AST=5×ULN for those with liver metastases; total bilirubin (TBIL)= 1.5×ULN (in patients with Gilbert syndrome, =3×ULN); iii. Renal function: Serum creatinine (Cr) =1.5×ULN or creatinine clearance (Ccr) =50ml/min (subjects receiving carboplatin) or =60ml/min (subjects receiving cisplatin) ; iv. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5×ULN; v. Cardiac echocardiography: left ventricular ejection fraction (LVEF) = 50%; 10) Women should agree that contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) must be used during the study period and within 6 months after the end of the study; a negative blood pregnancy test within 7 days before study enrollment, And must be non-lactating patients; men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1) Patients who are suitable for local treatment and willing to do local treatment; 2) Received systemic chemotherapy, excluding chemotherapy for locally advanced disease as part of multimodal therapy; chemotherapy (the end of this treatment must be more than 6 months after the first trial drug); Note: Multimodal treatment includes induction chemotherapy, concurrent chemoradiotherapy and adjuvant chemotherapy. 3) Disease progression within 6 months after the completion of multimodal treatment for locally advanced squamous cell carcinoma of the nasal cavity and paranasal sinuses; 4) Previous immunization with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs targeting T cell costimulation or immune checkpoint pathways treat; 5) Other malignancies that have occurred within 5 years or are concurrently present in the current period, except for cured cervical carcinoma in situ, non-melanoma skin cancer or other tumors/cancers that have undergone radical treatment and have no signs of disease for at least 5 years; 6) Received cetuximab treatment within 6 months before the first dose; 7) According to the criteria of common adverse event terms (NCI CTCAEv5.0), there is a peripheral neuropathy = grade 2; 8) With known active central nervous system metastases (CNS) and/or cancerous meningitis: Subjects with previously treated brain metastases can participate in the study, provided they are clinically stable for at least 2 weeks, with no new or expanded evidence of brain metastases, and steroids were discontinued 14 days prior to study drug administration. Stable brain metastases in this definition should be identified prior to the first dose of study drug. Subjects with asymptomatic brain metastases (ie, no neurological symptoms, no need for corticosteroids, and no lesions >1.5cm) can participate, but regular brain imaging examinations are required as the disease site; 9) Subjects who have not recovered from any acute effects of previous surgery, chemotherapy or radiotherapy, i.e. have not fallen to = grade 1 (NCI CTCAEv5.0) (excluding alopecia). Chronic late toxicity from previous radiotherapy and/or surgery (pharyngeal/laryngotoxicity, i.e. dry mouth, abnormal speech, swallowing, etc.) is allowed if nutritional status is stable; 10) Any component of the research drug or preparation has ever caused severe allergic reactions, including known severe allergic reactions to other monoclonal antibodies (NCI CTCAEv5.0=3 grade); 11) Received anti-tumor drug treatment (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) within 4 weeks or within 4 weeks before the first administration, except for palliative radiotherapy for bone pain relief; 12) Chinese herbal medicines or proprietary Chinese medicines receiving antitumor therapy =1 week before the first administration; 13) Received major surgery within 4 weeks before the first administration or is expected to undergo major surgery during this study; 14) Requires use of immunosuppressive drugs 2 weeks before or within 2 weeks of the first dose or during the study, excluding the following: a) intranasal, inhaled, topical steroids or topical steroid injections (e.g. intra-articular injections); b) Physiological doses of systemic corticosteroids (=10 mg/day prednisone or equivalent); c) Short-term (=7 days) use of steroids to prevent or treat non-autoimmune allergic diseases; 15) Subjects known t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the progression-free survival (PFS) of pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in first-line treatment of patients with recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses;To evaluate the objective response rate (ORR) of pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in first-line treatment of patients with recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the overall survival (OS) of pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in first-line treatment of patients with recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses;To evaluate other efficacy indicators of pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in the first-line treatment of patients with recurrent and metastatic nasal squamous cell carcinoma, including disease control rate (DCR), duration of response (DOR), 6-month and 12-month PFS rates;;To evaluate the safety and quality of life (QoL) of pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in the first-line treatment of patients with recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses; | — |
Countries
China
Contacts
Public ContactLin Gui
Outcome results
None listed