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).
The study randomly divided these three types of high-risk nasopharyngeal carcinoma into two groups. The experimental group received maintenance therapy with toripalimab and capecitabine, while the control group received maintenance therapy with capecitabine alone. The maintenance treatment period of the two groups was 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
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.
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China
NOT_YET_RECRUITINGFirst Affiliated hospital of Gannan Medical University
Guangzhou, Jiangxi, China
RECRUITINGDepartment of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, None Selected, China
RECRUITINGProgression-free Survival
Time from date of start of treatment to disease progression or death from any cause.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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