Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma (NCT07645846) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma
23 participantsStarted 2026-07-31
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
* Thyr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Pathological Response Rate(MPR)
Timeframe: From enrollment to the end of treatment at 9 weeks