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NOT YET RECRUITING
NCT07645846
PHASE2

Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Single-Arm, Phase II Trial of Neoadjuvant Docetaxel and Cisplatin Combined With Dual Immunotherapy for Locally Advanced Sinonasal Carcinoma (PANDA Study)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2026-07-31

Completion Date

2030-08-01

Last Updated

2026-06-25

Healthy Volunteers

No

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.