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Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)

Clinical Trial Summary

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).

Clinical Trial Description

The study randomly divided these three types of high-risk nasopharyngeal carcinoma into two groups. The experimental group received maintenance therapy with toripalimab and capecitabine, while the control group received maintenance therapy with capecitabine alone. The maintenance treatment period of the two groups was 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06277050
Study type Interventional
Source Jiangxi Provincial Cancer Hospital
Contact Jingao Li, MD
Phone 86079188300252
Email lijingao@hotmail.com
Status Recruiting
Phase Phase 3
Start date March 7, 2024
Completion date February 20, 2030
View Details
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