Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma

NCT07645846 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-FXY-123
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Locally Advanced Sinonasal Carcinoma

Keywords

Locally Advanced; Sinonasal Carcinoma; neoadjuvant therapy; dual immune checkpoint inhibitors; Docetaxel; Cisplatin

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 9 weeks

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  Up to 2 years

• 2-Year Overall Survival (OS) Rate

  2 years from the start of treatment

• Median Overall Survival (mOS)

  Up to 2 years

• 2-Year Progression-Free Survival (PFS) Rate

  2 years from the end of the last treatment

• Median Progression-Free Survival (mPFS)

  Up to 2 years

Study Arms (1)

Neoadjuvant Chemo-Immunotherapy

EXPERIMENTAL

Patients will receive neoadjuvant therapy consisting of Ipilimumab N01 (1 mg/kg, IV, Day 1 of Cycle 1), Sintilimab (200 mg, IV, Q3W for 3 cycles), Docetaxel (75 mg/m\^2, IV, Q3W for 3 cycles), and Cisplatin (60 mg/m\^2, IV, Q3W for 3 cycles). Radical surgery will be performed within 4 weeks after the completion of neoadjuvant therapy. Postoperative adjuvant radiotherapy with or without chemotherapy will be determined by the investigators and a multidisciplinary team (MDT) based on NCCN and CSCO guidelines.

Drug: Neoadjuvant Chemo-Immunotherapy

Interventions

Neoadjuvant Chemo-Immunotherapy DRUG

Drug: 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.

Neoadjuvant Chemo-Immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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. 4. 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.
• \. Hepatic function: Total bilirubin \< 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible); Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase \< 1.5 × ULN. For patients positive for hepatitis B surface antigen (HBsAg), HBV-DNA must be ≤ 1000 IU/mL, and prophylactic antiviral therapy is required during the study.
• \. Renal function: Serum creatinine \< 1.5 × ULN, or creatinine clearance ≥ 60 mL/min as calculated by the Cockcroft-Gault formula.
• \. Coagulation: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN. Patients receiving stable doses of anticoagulant therapy (e.g., low molecular weight heparin or warfarin) with an INR within the expected therapeutic range are eligible.
• \. Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels will be evaluated, and patients with normal T3 and T4 levels are eligible.
• \. Contraception: Women of childbearing potential must agree to use highly effective contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the treatment period and for at least 3 months after the last dose. They must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating. Male patients must agree to use highly effective contraceptive measures during the study period and for at least 3 months after the last dose.
• \. Informed Consent: Voluntary participation with written informed consent signed.

You may not qualify if:

• \. 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).
• \. Use of high-dose glucocorticoids or traditional Chinese medicine with anti-tumor properties within 4 weeks prior to the first dose of the study drug.
• \. Prior vaccination with an anti-tumor vaccine, or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug.
• \. Receipt of any investigational drug within 4 weeks prior to the first dose of the study drug.
• \. Presence of comorbidities requiring long-term immunosuppressive therapy, or requiring systemic or local administration of corticosteroids at immunosuppressive doses prior to enrollment.
• \. Concurrent Trials: Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
• \. Recent Medical Events: Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.
• \. Organ Transplantation: History of organ transplantation. 12. Autoimmune Diseases: Known or suspected active autoimmune disease. 13. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
• \. Concurrent positive HBsAg and positive HBV DNA copy number (quantitative detection ≥ 1000 cps/mL). Positive blood screening for chronic hepatitis C (HCV antibody positive). Concurrent HBV and HCV co-infection. (Note: Patients with normal liver function who have been on oral antiviral therapy for more than one week may be eligible).
• \. Failure to meet relevant laboratory criteria within 7 days prior to enrollment; abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5 g/L), bleeding tendency, or undergoing active thrombolytic or anticoagulant therapy.
• Significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function. History of dementia or seizures.
• \. Severe Infections: Severe infection (CTCAE \> Grade 2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging indicating active pulmonary inflammation; presence of signs and symptoms of infection within 2 weeks prior to the first dose of the study drug, or requiring oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics).

Sponsors & Collaborators

• Sun Yat-sen University: lead
• 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

Study Officials

• Xuekui Liu

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

• Chunyan Chen

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiyue Mao

CONTACT

86-020-87342926; maokaiyue@sysucc.org.cn

Xiaoyun Feng

CONTACT

fengxy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Model Details: A Simon's two-stage minimax design is adopted for this single-arm study to evaluate the efficacy and safety of the neoadjuvant combination therapy.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 6 months and ending 36 months following the publication of the primary research article.
• Access Criteria: Data will be shared with qualified researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a formal data access agreement, and the data will only be used for achieving the aims specified in the approved proposal.