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RECRUITING
NCT07154069
PHASE3

Adaptive Immunotherapy for Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

Official title: Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

802

Start Date

2025-11-13

Completion Date

2033-09

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

RADIATION

Radical radiotherapy of nasopharynx and neck

Radical radiotherapy of nasopharynx and neck

DRUG

Capecitabine

Adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year

DRUG

Concurrent chemoradiotherapy (cCRT)

Concurrent chemoradiotherapy

DRUG

Toripalimab

Adjuvant Toripalimab (240mg day1, Q3W )

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China