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.
Currently, there is a lack of prospective phase II/III clinical evidence to guide the optimal treatment of locally advanced sinonasal carcinoma (SNC). Based on current clinical guidelines for head and neck squamous cell carcinoma (HNSCC), the investigators hypothesize that the combination of TP chemotherapy with dual immune checkpoint inhibitors (targeting PD-1 and CTLA-4) could significantly improve the major pathological response (MPR) and achieve superior organ function preservation in patients with locally advanced SNC. By evaluating the TP regimen combined with sintilimab and ipilimumab N01, this trial seeks to validate the feasibility of organ function preservation under this therapeutic modality. If successful, this treatment strategy will establish a novel precision treatment paradigm that effectively balances tumor control with organ function preservation, laying a solid foundation for subsequent phase III randomized controlled trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
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.
Time frame: From enrollment to the end of treatment at 9 weeks
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.
Time frame: Up to 2 years
2-Year Overall Survival (OS) Rate
Defined as the percentage of participants who are alive 2 years after the initiation of treatment.
Time frame: 2 years from the start 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.
Time frame: Up to 2 years
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.
Time frame: 2 years from the end of the last treatment
Median Progression-Free Survival (mPFS)
Defined as the time from the start of treatment until disease progression or death in 50% of the evaluable patients.
Time frame: Up to 2 years
Duration of Response (DoR)
Evaluated per RECIST v1.1.
Time frame: From the first documented CR or PR until the first documented tumor progression or death from any cause, assessed up to 2 years
Disease Control Rate (DCR)
Defined as the percentage of patients who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment.
Time frame: Up to 2 years
R0 Resection Rate
Defined as the percentage of patients achieving a complete tumor resection with microscopically negative margins.
Time frame: At the time of surgery (assessed up to 4 weeks after completion of neoadjuvant therapy)
Organ Functional Preservation Rate (OFPR)
Defined as the percentage of living patients at 2 years post-treatment who do not require salvage radical surgery and successfully preserve major physiological functions. Patients must meet all 4 conditions: Maxilla \& Oral: No total maxillectomy (limited/scaffold-preserving excision allowed); no permanent tube feeding; intelligible speech; no severe trismus (mouth opening \>2.5cm). Orbit \& Vision: No enucleation/orbital exenteration; ipsilateral vision better than light perception (≥0.05); no intractable diplopia, severely restricted eye movement, or eyelid dysfunction causing exposure keratitis. Skull Base \& Neurological: No massive cranial/dural defect from extensive resection; no persistent CSF leak; no severe treatment-induced CNS complications. Appearance: No obvious facial collapse or disfigurement; adequate subjective satisfaction (FACE-Q scale); no external facial prosthesis required.
Time frame: At 2 years post-treatment
Change in Quality of Life Scores (QOL)
The psychological state and overall quality of life of the patients will be evaluated using the QOL-V30 questionnaire. Higher scores generally represent a higher quality of life or level of functioning.
Time frame: Baseline and up to 2 years
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