NCT06438627 Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.

Eligibility Criteria

Inclusion Criteria: 1. Pathologically confirmed WHO type II or III; 2. Staging TanyN3M0 (UICC/AJCC 8th edition); 3. Treatment-naive patients with no history of other malignancies; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5. Age 18-65 years; 6. Neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L, transaminases \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal, creatinine \<1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio \<1.5 times the upper limit of normal; 7. Signed informed consent form. Exclusion Criteria: 1. Known or suspected allergy to the study drugs, or pregnant/perinatal women; 2. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons; 3. Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver f

Related Trials