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).
The trial plans to enroll patients with stage T4N1and T1-4N2-3 (AJCC 9th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus QL1706 in induction chemotherapy and adjuvant chemotherapy. All patients will receive intensity-modulated radiotherapy (IMRT). QL1706 will begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in induction therapy and for 9 cycles in adjuvant therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
580
QL1706 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 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Fujian Cancer Hospital
Fuzhou, Fujian, China
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.
Time frame: 3 years
Overall survival (OS) in intention-to-treat population
Multiple endpoint 2: calculated from randomization to the date of death from any cause.
Time frame: 5 years
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.
Time frame: 3 years
Overall survival (OS) in per-protocol population
calculated from randomization to the date of death from any cause.
Time frame: 3 years
Locoregional recurrence-free survival (LRRFS)
calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence.
Time frame: 3 years
Distant metastasis-free survival (DMFS)
calculated from randomization to the date of first distant metastasis.
Time frame: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
Time frame: 3 years
Quality of life (QoL)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Dongguan People's Hospital
Dongguan, Guangdong, China
NOT_YET_RECRUITINGFirst People's Hospital of Foshan
Foshan, Guangdong, China
NOT_YET_RECRUITINGGuangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGZhongshan People's Hospital
Zhongshan, Guangdong, China
NOT_YET_RECRUITINGCancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGCancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGHubei Province Cancer Hosiptal
Wuhan, Hubei, China
NOT_YET_RECRUITINGRenmin Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 9 more locations
The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL 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.
Time frame: week 1, 20, 40, 64
Failure-free survival (FFS) within different subgroups
analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. \>4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage (III vs. IVA).
Time frame: 3 years
Tumor response
Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians
Time frame: Every 6 weeks(the time of completion of induction chemotherapy, radiotherapy, and adjuvnt immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 74 weeks)