This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
Nasopharyngeal carcinoma (NPC) is endemic in southern China, southeast Asia, and northern Africa. According to a survey from the International Agency for Research on Cancer, there were an estimated 129,079 new cases and 72,987 related deaths in 2018. Radiotherapy is the primary treatment option. Due to advances in disease management, diagnostic imaging, radiotherapy technology, and the broader application of systemic therapy, the prognosis of NPC has improved signifificantly.Nevertheless, localregional recurrence will occur in about 10% patients. Because of radiation resistance, the prognosis of re-irradiation is poor for recurrent nasopharyngeal carcinoma. Hence, there is an urgent need for novel therapies to improve survival and reduce treatment-related toxicity in recurrent NPC patients. Emerging evidence shows that PD-1 antibody is effective for treating recurrent/metastastic NPC patients. This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with concurrent chemoradiotherapy (CCRT) versus CCRT alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
anti-PD-1 antibody
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGOverall survival (OS)
Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 5 years
Progress-free survival (PFS)
Defined from date of randomization to date of first documentation of progression or death due to any cause.
Time frame: 5 years
Objective Response Rate (ORR)
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) .
Time frame: 3 months
Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
Time frame: 5 years
Change of QoL (quality of life)
QoL scores were assessed by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before radiotherapy, at the end of radiotherapy, at 12 months after radiotherapy.
Time frame: 1 year
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