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Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma

NCT07645846 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-06-25

No results posted yet for this study

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

Interventions

DRUG

Neoadjuvant Chemo-Immunotherapy

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Zhujiang Hospital

    collaborator OTHER

  • Qingyuan People's Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xuekui Liu · Sun Yat-Sen University Cancer Center

  • Chunyan Chen · Sun Yat-Sen University Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-08-01
Completion
2030-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645846 on ClinicalTrials.gov