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).
Pathologically confirmed nasopharyngeal carcinoma;
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 induction chemotherapy.
Recurrent or distant metastatic nasopharyngeal carcinoma.
History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
Has received prior therapy with an anti-PD-1 mab.
Parallel
Maintenance Therapy with Toripalimab and Capecitabine
DrugCapecitabine 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.
Maintenance Therapy with Capecitabine
DrugCapecitabine 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.
Progression-free Survival
Time from date of start of treatment to disease progression or death from any cause.
Distant Metastasis-Free Survival
Time from date of start of treatment to documented distant metastasis or death from any cause, patients with locoregional relapse as a first event will be censored at date of locoregional relapse.
Overall Survival
Time from date of start of treatment to death from any cause, where patients lost to follow-up were censored at the date of last follow-up.
Loco-Regional Recurrence-Free Survival
Time from date start of treatment to documented locoregional relapse or death from any cause, patients with distant metastasis as a first event will be censored at the date of distant metastasis.
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