NCT03701451

Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma

Clinical Efficacy Observation of Demethylated Drug Decitabine in the Treatment of Locally Advanced Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wei Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is to observe the efficacy and toxicity of demethylating drug decitabine and cisplatin induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy in the treatment of regionally advanced nasopharyngeal carcinoma,followed up for 2 years, observing the 2-year survival rate and variation of degrees of methylation before and after treatment,providing clinical basis for the clinical study of stage II-III.

Detailed description

Recent studies and previous studies in the investigator's research group have found that nasopharyngeal carcinoma is a disease with hypermethylation changes, and epigenetic treatment has not yet been carried out in nasopharyngeal carcinoma. In this study, Simon's two-stage design method was used to select 30 patients with nasopharyngeal carcinoma, treated with demethylating drug decitabine 7mg/m2 d1-5 + cisplatin 80mg/m2 d1 induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy with cisplatin 80mg/m2. observing the efficacy and toxicity of decitabine in the treatment of regionally advanced nasopharyngeal carcinoma, followed up for 2 years, observing the 2-year survival rate,evluating the relationship between different degrees of methylation and survival before and after treatment,provide clinical basis for the clinical study of stage II-III.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Demethylated drug decitabine	Induced treatment by demethylating drug decitabine 7mg/m2 d1-5 and cisplatin 80mg/m2 d1 for 3 cycles to regionally advanced nasopharyngeal carcinoma followed by concurrent chemoradiotherapy with cisplatin 80mg/m2 d1 for 3 cycles.

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-10-10
• Last updated: 2018-10-10

Locations

2 sites across 1 country: China