Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)
Jiangxi Provincial Cancer Hospital
264 participants
Mar 7, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
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Interventions
Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.
Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.
Locations(3)
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NCT06277050