Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Recruiting Phase 3 Interventional Study
Nasopharyngeal Carcinoma High-Risk Cancer Maintenance 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
264 (estimated)
Sponsor
Jiangxi Provincial Cancer Hospital · Other
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About This Trial
N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. T…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Pathologically confirmed nasopharyngeal carcinoma; 2. High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induc…
Contacts

Jingao Li, MD

86079188300252

lijingao@hotmail.com

CONTACT

Xiaochang Gong, MD

86079188300252

gxcanddw@163.com

CONTACT