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Clinical Study of Immunotherapy Combined with Chemotherapy versus Chemotherapy for Locally Advanced Sinonasal Carcinoma

A Multicenter, Randomized Phase II Clinical Study of Neoadjuvant Toripalimab Combined with Chemotherapy versus Neoadjuvant Chemotherapy for Locally Advanced Sinonasal Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124761
Enrollment
Unknown
Registered
2026-05-17
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinonasal carcinoma

Interventions

Neoadjuvant toripalimab combined with chemotherapy group:Tislelizumab + neoadjuvant chemotherapy

Sponsors

Eye & ENT hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 years and 2000/mm^3, platelet count >100,000/mm^3; 9. Pre-treatment liver and kidney function tests meeting the following conditions: bilirubin 60 ml/min; 10. Signed informed consent before the start of the study.

Exclusion criteria

Exclusion criteria: 1. Malignant tumors of the nasal cavity and paranasal sinuses with pathological types other than squamous cell carcinoma or undifferentiated carcinoma; 2. Cases not confirmed through multidisciplinary team (MDT) discussion; 3. Unsuitable for enhanced MRI imaging evaluation; 4. Cases staged as I-II or IVC according to the UICC/AJCC 8th edition staging criteria; 5. Clinical or imaging evidence of distant metastasis, or suspected evidence thereof; 6. History of radiotherapy for head and neck malignancies or presence of multiple primary tumors (excluding basal cell carcinoma of the skin); 7. Positive pregnancy test in women of childbearing age; 8. Concomitant diseases or conditions that affect the patient's normal enrollment or safety during the study; 9. Active psychiatric disorders or other psychological conditions affecting the patient's ability to provide informed consent and understand the study; 10. Uncontrolled active infection.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate, ORR;

Countries

China

Contacts

Public Contactwangli

Eye & ENT hospital of Fudan University

qy12wangli@163.com+86 18917785471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026