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Adaptive Immunotherapy for Nasopharyngeal Carcinoma

NCT07154069 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Cancinoma (NPC)

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 )

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2031-09-30
Completion
2033-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154069 on ClinicalTrials.gov