The main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). The treatment consists of the standard TP chemotherapy regimen (docetaxel and cisplatin) combined with dual immunotherapy (sintilimab and ipilimumab N01) administered before surgery. Researchers aim to determine the major pathological response (MPR) rate and long-term survival outcomes, while also exploring if this combination treatment approach can help better preserve critical facial and organ functions for SNC patients.
Disease Status: Newly diagnosed, pathologically confirmed locally advanced (AJCC 8th edition Stage III-IVA) sinonasal carcinoma (SNC).
Suitable for radical comprehensive treatment, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
18 to 75 years old.
Defined by the following laboratory test results obtained within 7 days prior to enrollment: Hematology (without blood transfusion or hematopoietic growth factor therapy within 14 days prior to testing): White blood cell (WBC) count ≥ 4.0 × 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L; Platelet (PLT) count ≥ 100 × 10^9/L.
History of other malignancies within the past 5 years, except for curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
Presence of residual measurable lesions or new tumor/metastasis according to RECIST 1.1 criteria, or deemed inoperable by a head and neck surgeon.
History of severe hypersensitivity reactions to other monoclonal antibodies or any components of the PD-1 inhibitors.
Prior and Concomitant Therapies: Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation or checkpoint pathways).
Single group
Neoadjuvant Chemo-Immunotherapy
DrugDrug: Ipilimumab N01, 1mg/kg, D1C1. Drug: Sintilimab, 200mg, Q3W, C1C2C3. Drug: Docetaxel, 75mg/m2, Q3W, C1C2C3. Drug: Cisplatin, 60mg/m2, Q3W, C1C2C3. Procedure: Radical Surgery. Radiation: Adjuvant Radiotherapy.
Major Pathological Response Rate(MPR)
Defined as the percentage of participants whose resected tumor specimens show ≤10% viable tumor cells upon microscopic examination following neoadjuvant therapy.
Objective Response Rate (ORR)
Defined as the proportion of patients who achieve a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
2-Year Overall Survival (OS) Rate
Defined as the percentage of participants who are alive 2 years after the initiation of treatment.
Median Overall Survival (mOS)
Defined as the time from the start of treatment to death from any cause in 50% of the evaluated patients.
2-Year Progression-Free Survival (PFS) Rate
Defined as the percentage of participants who remain alive and free of disease recurrence, new metastasis, or disease progression 2 years after the completion of the last treatment.
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Sun Yat-sen University
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Zhujiang Hospital
Collaborator
Qingyuan People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
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