OncoMatch/Clinical Trials/NCT07327216
Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
Is NCT07327216 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sapylin and Dexamethasone for nasopharyngeal carcinoma (npc).
Treatment: Sapylin · Dexamethasone · CCRT with Cisplatin — Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity. Current clinical guidelines from organizations like MASCC/ISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone. This study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered this way may enhance the effectiveness of chemotherapy and boost the body's immunity. The main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT. By participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Prior therapy
Cannot have received: radiotherapy
No previous radiotherapy
Cannot have received: chemotherapy
No previous chemotherapy
Cannot have received: surgery
No previous surgery
Cannot have received: immunization
No previous immunization
Cannot have received: targeted therapy
No previous targeted therapy
Cannot have received: chemoradiotherapy
Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy
Cannot have received: targeted immunotherapy
Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy
Lab requirements
Blood counts
white blood cell count ≥4.0×10^9/l, hemoglobin ≥100g/l, neutrophil count ≥1.5×10^9/l, platelet count ≥100×10^9/l
Kidney function
estimated glomerular filtration rate ≥60 ml/min
Liver function
total bilirubin ≤1.5×uln, alt and ast ≤2×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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