Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07392320
Brief Summary:
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Detailed Description:
For high-risk locally advanced nasopharyngeal carcinoma, it remains essential to explore more effective treatment strategies and regimens. In the era of immunotherapy, the introduction of PD-1 monoclonal antibodies has provided significant survival benefits to patients with locally advanced nasopharyngeal carcinoma. However, different modes of intervention still warrant further exploration, and additional clinical evidence is needed for validation.
In this study, the investigators designed a randomized, open-label, phase II clinical trial focusing on high-risk locally advanced nasopharyngeal carcinoma (defined as T4 or N3 or EBV DNA ≥1500 copies/ml according to AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares the sequential approach of TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus maintenance therapy with capecitabine. The study aims to provide high-quality clinical evidence to optimize treatment strategies for high-risk locally advanced nasopharyngeal carcinoma.
Study:
NCT07392320
Study Brief:
Protocol Section:
NCT07392320