Clinical trial · Interventional
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
A Phase 3, Open Label, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ulinastatin in the Reduction of Acute Oral Mucositis Caused by Concurrent Chemoradiotherapy(CCRT) for Patients With Localregionally Advanced Nasopharyngeal Carcinoma (NPC).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis (Ulcerative) Due to Radiation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Ulinastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concurrent chemoradiotherapy and ulinastatin
- description
- Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows: 1. Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT; 2. Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.
- interventionNames
- Drug: Cisplatin
- Radiation: Intensity Modulated Radiation Therapy
- Drug: Ulinastatin
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy
- description
- Concurrent chemoradiotherapy (CCRT) alone: Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.
- interventionNames
- Drug: Cisplatin
- Radiation: Intensity Modulated Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis * Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition) * Karnofsky Performance Status Scale between 80-100 * WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L * ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min * Sign the informed consent. Exclusion Criteria: * Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas * Younger than 18 years old or older than 70 years old * Pregnancy or lactation * Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes * Have suffered from other tumor or now suffering from other tumor * Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases * Refuse to give up smoking/drinking/betel chewing * suffering from other active infection diseases and in need of treatment.
References
Publications (0)
Data not yet available