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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Feb 20, 2029 to Feb 20, 2030
    • Study completion date: Feb 20, 2030 to Feb 20, 2031
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v4
  3. Start date: Feb 20, 2024 to Mar 7, 2024v3
  4. Eligibility criteria expanded, about 1 wordv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).
Trial Details
NCT Number NCT06277050
Lead Sponsor Jiangxi Provincial Cancer Hospital
Conditions
(from sponsor)		 Nasopharyngeal Carcinoma, High-Risk Cancer, Maintenance Therapy
Related terms Nasopharyngeal Carcinoma
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov