Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma

Recruiting Phase 3 Interventional Study
Nasopharyngeal Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
556 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial

This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age at diagnosis: 18 \~ 65 years old; 2. Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)"; 3. Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) w…
Contacts

Jun Ma, MD

+862087343469

majun2@mail.sysu.edu.cn

CONTACT

Yuan Zhang, PhD

+862087343469

zhangyuan@sysucc.org.cn

CONTACT