OncoMatch/Clinical Trials/NCT06277050
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Is NCT06277050 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT06277050 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy or systemic anti-cancer therapy including investigational agents for NPC, anti-PD-1 monoclonal antibody, herbal medicine used to control cancer disqualifies patients from enrollment.
Does this trial require EBV?
Yes, EBV detectable DNA after 2 cycles of induction chemotherapy is a required biomarker for enrollment.
What disease stage is eligible?
Stage TANYN3M0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages