Toripalimab with Concurrent Chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is a type of cancer common in Southern China and Southeast Asia. For advanced NPC, particularly high-risk cases with plasma EBV DNA levels at 1500 copies/ml or higher, treatment failure rates remain high. Current treatments like concurrent chemoradiotherapy (CCRT) aim to improve patient outcomes, but around 25% of advanced NPC patients still experience relapse or metastasis. Therefore, there's an urgent need for new treatments to enhance survival and decrease side effects. Research suggests that PD-1 antibody therapy, such as Toripalimab, could be beneficial for patients with recurrent or metastatic NPC. This Phase II clinical trial investigates the effectiveness and safety of Toripalimab combined with CCRT, compared to CCRT with a placebo, for high-risk NPC patients (Stage III-IVa, AJCC 8th, and EBV DNA ≥ 1500 copies/ml). In this study, participants are randomly assigned to receive either Toripalimab in combination with CCRT or CCRT with a placebo. The primary goal is to evaluate progression-free survival (PFS), which is the time from randomization to the first instance of disease progression or death from any cause. This trial aims to determine whether adding Toripalimab to the current standard treatment can improve patient outcomes and reduce the risk of relapse or metastasis.