This is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy (Albumin-bound paclitaxel and cisplatin )and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the biomarkers that can predict the efficacy and toxicity of the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy
Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy
Adverse events
Incidence of adverse events as assessed by CTCAE v5.0
Time frame: 2 years
Overall survival (OS)
calculated from randomization to the date of death from any cause.
Time frame: 3 years
Distant failure-free survival (DFFS)
calculated from randomization to the date of first distant metastasis.
Time frame: 3 years
Locoregional failure-free survival (LRFFS)
calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence
Time frame: 3 years
Overall response rate (ORR)and Complete response rate(CR)
Defined as percentage of participants achieving complete response (CR) and partial response (PR) according to the RECIST 1.1.
Time frame: 2 years
Quality of life (QoL)
The change of QoL from randomization to 12 months after chemoradiation. The European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ-C30)version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual: 1. Estimate the average of the questions that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100. Thus, a high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high QoL, but a high score for a symptom scale represents a high level of problems.
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Definitive IMRT of ≥66 Gy will be given .
Time frame: 3 years