Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Toripalimab (240 mg Q3W for 3 cycles) combine with chemotherapy
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGComplete Response
CR assessed by investigator, according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI). Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging.
Time frame: 9 weeks
Overall Survival(OS)
defined as the time from random assignment to death from any cause or censored at the date of last follow-up.
Time frame: 3 years
Locoregional failure-free survival(LRRFS)
defined as the time from random assignment to local or regional relapse, or death from any cause.
Time frame: 3 years
Distant metastasis-free survival(DMFS)
defined as the time from random assignment to distant metastasis, or death from any cause.
Time frame: 3 years
Number of participants with adverse events
Numbers of patients of treatment-related adverse events were assessed by CTCAE v5.0.
Time frame: up to 3 years
Quality of life (QoL): questionnaire
QoL is evaluated with the use of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30), which is established by European Organization for Research and Treatment of Cancer (EORTC). Scores for the module range of H\&N35 QLQ-C30 from 0 to 100, with higher scores indicating better functioning or well-being or higher symptom burden (scales measuring symptom burden were reverse-scored to facilitate presentation)
Time frame: Week 1,9,16,28
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