Neoadjuvant finotonlimab plus TP chemotherapy for SMARCB1-deficient sinonasal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm phase 2 trial enrolling adults with locally advanced INI-1/SMARCB1-deficient sinonasal carcinoma. Participants receive two cycles of neoadjuvant therapy: finotonlimab on day 1, followed by paclitaxel and cisplatin every 21 days. Tumor response is assessed with imaging and central RECIST review, guiding subsequent definitive surgery and postoperative radiotherapy. The goal is to improve preoperative tumor downstaging and enable a higher rate of complete resections while preserving organ function. Safety and efficacy will be monitored throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, male or female.
2. Complete loss of nuclear INI-1 (SMARCB1) expression in tumor cells confirmed by central pathology immunohistochemistry, with a pathological diagnosis of primary malignant tumor of the sinonasal cavity and skull base.
3. No prior radiotherapy of any type, including proton/heavy-ion radiotherapy or intensity-modulated radiotherapy.
4. AJCC 8th edition stage T3, T4a, or T4b; N0-N2 lymph node metastasis is allowed; isolated distant metastases assessed by MDT as stable and amenable to concurrent local treatment are allowed; extensive multiple distant metastases are excluded.
5. MDT assessment indicates extensive local invasion of the skull base and/or orbit, high difficulty for direct surgery, high risk of residual disease, and suitability for neoadjuvant downstaging.
6. ECOG performance status 0-1 and expected survival ≥6 months.
7. Baseline laboratory values meet treatment safety standards: absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L; ALT/AST ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN; creatinine clearance ≥60 mL/min; LVEF ≥50%; and no significant thyroid dysfunction.
8. Voluntary participation with full understanding of benefits and risks, and signing of two copies of the informed consent form.

Exclusion Criteria:

1. Prior use of PD-1/PD-L1 inhibitors, taxane chemotherapy, or platinum-based chemotherapy.
2. History of severe allergy to finotonlimab, paclitaxel, cisplatin, or any of their excipients.
3. Active autoimmune disease, interstitial lung disease, active tuberculosis, or uncontrolled severe infection.
4. Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or severe hepatic or renal failure.
5. History of another malignancy within 5 years, except adequately treated basal cell skin cancer or carcinoma in situ.
6. Pregnant or breastfeeding women.
7. Men or women of childbearing potential who are unwilling to use adequate contraception during treatment and for 6 months after the end of treatment.
8. Participation in another anticancer clinical trial within 30 days before enrollment.
9. Psychiatric disorders, poor compliance, or inability to complete follow-up.
10. Extensive multiple intracranial metastases or inability to tolerate systemic treatment.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Quan Liu, MD
• Email: liuqent@163.com
• Phone: 15001959681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.