A Multicenter, Randomized Controlled Phase III Trial of Induction Plus Concurrent Chemoradiotherapy Plus Camrelizumab or Nimotuzumab Versus Induction Plus Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+.
- •Age 18-70 years.
- •Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition).
- •Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant.
- •ECOG (Eastern Cooperative Oncology Group) score: 0-1
- •Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
- •Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN.
- •Renal function: serum creatinine <1×ULN.
- •Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
排除标准
- •Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- •Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- •Receiving radiotherapy or chemotherapy or targeted therapy previously
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- •Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- •Severe, uncontrolled medical conditions and infections.
- •At the same time using other test drugs or in other clinical trials.
- •Refusal or inability to sign informed consent to participate in the trial.
- •Emotional disturbance or mental
研究组 & 干预措施
the combination of camrelizumab and standard treatment
camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.
干预措施: Camrelizumab (Drug)
the combination of camrelizumab and standard treatment
camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.
干预措施: neoadjuvant chemotherapy and CCRT (Drug)
the combination of nimotuzumab and standard treatment
nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.
干预措施: Nimotuzumab (Drug)
the combination of nimotuzumab and standard treatment
nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.
干预措施: neoadjuvant chemotherapy and CCRT (Drug)
standard treatment
the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.
干预措施: neoadjuvant chemotherapy and CCRT (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
Defined from date of randomization to date of first documentation of progression or death due to any cause
次要结局
- Overall survival(3 years)
- Toxicities(3 years)