This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSuizhou Central Hospital
Suizhou, Hubei, China
RECRUITINGGanzhou Cancer Hospital
Ganzhou, Jiangxi, China
Progress-free survival (PFS)
From date of randomization to date of first documentation of progression or death due to any cause.
Time frame: 3 year
Overall Survival (OS)
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: 3 year
Distant Metastasis-Free Survival (DMFS)
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
Time frame: 3 year
Locoregional Relapse-Free Survival (LRRFS)
From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
Time frame: 3 year
Objective Response Rate （ORR）
Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Time frame: within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
adverse events (AEs)
Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Time frame: 3 year
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70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
First Affiliated hospital of Gannan Medical University
Guangzhou, Jiangxi, China
RECRUITINGJiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
RECRUITINGJiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGPingxiang Peoples' Hospital
Pingxiang, Jiangxi, China
RECRUITING