2770 - A Randomized, Controlled, Single-Blind, Multicenter Phase II/III Clinical Trial of PD-1 Inhibitor Combined with Chemoradiotherapy for the Treatment of T1-2N2-3/T3-4N0-3M0 Stage Nasopharyngeal Carcinoma — Study Protocol
Presenter(s)
W. Weidong1, H. Jia2, H. Li3, W. Luo4, and W. Zou5; 1Sichuan Cancer Hospital & Institute, Chengdu, China, 2Sichuan Cancer Hospital and Institute, Chengdu, Sichuan, China, 3The Second People’S Hospital of NEIJIANG, Neijiang, China, 4The First People’S Hospital of mianyang, Mianyang, China, 5Meishan Cancer Hospital, Meishan, China
Purpose/Objective(s): Nasopharyngeal cancer(NPC) is a common head and neck cancer with about 80,000 new cases of nasopharyngeal cancer worldwide every year. At present, concurrent chemoradiotherapy with adjuvant chemotherapy is standard treatment mode for locally advanced NPC (LANPC), but previous studies suggest that the treatment efficacy is not ideal with about 25% of patients with LANPC still have recurrence and metastasis. It is urgent to further optimize the combination therapy by exploring efficient and low toxicity treatment for these patients. Previous studies suggests that chemotherapy plus PD-1 inhibitor has improved outcomes of metastatic or recurrent NPC. However, in LANPC, it is unknown whether the addition of PD-1 inhibitor could improve efficacy. Therefore, this study is designed to explores the efficacy and safety of PD-1 inhibitors combined with chemoradiotherapy in the treatment of LANPC.
Materials/Methods: The study is a single blinded, multicenter, randomized, phase II/III clinical trial designed to evaluate the efficacy and safety of Toripalimab in combination with CRT followed by induction chemotherapy in patients with LANPC conducted in six centers in China. Patients with stage III–IVA NPC, as defined by the American Joint Committee on Cancer (AJCC) 8th edition staging system, were eligible for inclusion. Patients were eligible if they met the following criteria: histologically confirmed diagnosis of NPC; stage III–IVA; age 18–70 years; ECOG performance status of 0–1; no prior history of immunotherapy, and no active autoimmune disease; adequate organ function etc. Exclusion criteria included: prior head and neck cancer treatment (surgery, chemotherapy, or radiotherapy); active infection or severe systemic illness etc. Patients were randomly assigned to control or experimental arms in a ratio of 1:1. Patients in both weeks). Regime of induction chemotherapy is gemcitabine (1200mg/m2 d1,8) plus cisplatin (75mg/m2 d1). Patients in the experimental arm received Toripalimab (240 mg, intravenous) every 3 weeks starting with induction chemotherapy for a total of 7 weeks, while patients in control arm received placebo. The primary endpoint was progression-free survival (PFS). The secondary endpoints include: Overall survival (OS), Objective Response Rate (ORR) and safety. Treatment response is assessed by RECIST 1.1 criteria. Safety was assessed based on the incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The sample size was calculated based on an expected 12-month PFS rate of 60% in the CRT-alone group and 80% in the CRT + Toripalimab group, with an a of 0.05 and power of 80%. Enrollment began in April 2024. To date, 102 patients have been enrolled in the study. The Ethics Committee of Sichuan Cancer Hospital has approved this study, with the ethics approval number: KY-2021-113. Research sponsor: Shanghai Junshi Biosciences Co., Ltd.
Results: TBD
Conclusion: TBD. Registration Number: ChiCTR2200055494.