The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).
Age ≥18 and ≤65 years
Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
Stage II: T1-3N2
Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).
Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
Parallel
QL1706
DrugQL1706 5mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.
Gemcitabine
DrugGemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Cisplatin
DrugInduction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Intensity-modulated radiotherapy
RadiationDefinitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Failure-free survival (FFS) in intention-to-treat population
Multiple endpoint 1: calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Overall survival (OS) in intention-to-treat population
Multiple endpoint 2: calculated from randomization to the date of death from any cause.
Failure-free survival (FFS) in per-protocol population
calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Overall survival (OS) in per-protocol population
calculated from randomization to the date of death from any cause.
Locoregional recurrence-free survival (LRRFS)
calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence.
Distant metastasis-free survival (DMFS)
calculated from randomization to the date of first distant metastasis.
Correlation between pre-treatment PD-L1 expression level and FFS
Pre-treatment PD-L1 expression level of tumor cell is evaluated centrally by means of immunohistochemical testing.
Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level
Subgroup analysis
Evaluate failure-free survival in the subgroup of clinical stage
Subgroup analysis
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Sun Yat-Sen University Cancer Center
Lead sponsor
Sun Yat-sen University
Sponsor institution
Qilu Pharmaceutical Co., Ltd.
Collaborator
