Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

Recruiting Phase 3 Interventional Study
Nasopharyngeal Cancer Chemotherapy Radiotherapy PD-1 Therapy
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 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
388 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). 2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition). 3. Staged as T1-3N1-2M0, T2-3N0M0 (stage I…
Contacts

Ming-Yuan Chen, MD, PhD

: 86-20-87343624

chmingy@mail.sysu.edu.cn

CONTACT

Rui You, MD, PhD

86-13580439820

yourui@sysucc.org.cn

CONTACT