OncoMatch/Clinical Trials/NCT06277050
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Is NCT06277050 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Maintenance Therapy with Toripalimab and Capecitabine and Maintenance Therapy with Capecitabine for nasopharyngeal carcinoma.
Treatment: Maintenance Therapy with Toripalimab and Capecitabine · Maintenance Therapy with Capecitabine — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EBV detectable DNA after 2 cycles of induction chemotherapy
Detectable EBV DNA after 2 cycles of induction chemotherapy
Disease stage
Required: Stage TANYN3M0
Excluded: Stage DISTANT METASTATIC
Grade: high-grade rENE
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: induction chemotherapy
Received 2-3 cycles of induction chemotherapy
Must have received: concurrent chemoradiotherapy (intensity-modulated radiotherapy)
concurrent chemoradiotherapy (intensity-modulated radiotherapy)
Cannot have received: radiotherapy or systemic anti-cancer therapy including investigational agents for NPC
Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
Cannot have received: anti-PD-1 monoclonal antibody (toripalimab)
Has received prior therapy with an anti-PD-1 mab
Cannot have received: herbal medicine used to control cancer
Has received any herbal medicine used to control cancer within 14 days of the start of study
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥ 75×10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine ≤1.5x ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L
Liver function
serum total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN (for subjects with liver metastases, TBIL ≤3x ULN; ALT and AST≤5x ULN)
Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥ 75×10^9/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN (for subjects with liver metastases, TBIL ≤3x ULN; ALT and AST≤5x ULN); Creatinine ≤1.5x ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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