NCT04557020招募中3 期
Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
Jiangxi Provincial Cancer Hospital7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
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 69 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
- •Clinical staged as T4 or N3 （according to the 8th AJCC edition）
- •No evidence of distant metastasis (M0)
- •Male and no pregnant female
- •ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- •WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- •Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- •Normal renal function test ( creatinine clearance ≥60 ml/min)
排除标准
- •Recurrent or distant metastatic disease.
- •History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- •History of radiotherapy or chemotherapy.
- •History of immunodeficiency disease
- •History of organ transplantation
- •Presence of life-threatening illness
- •Uncontrolled hypercalcemia
- •Severe uncontrolled medical conditions or active infectious diseases
- •Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
- •Pregnant or breastfeeding female
- •Emotional disturbance or mental illness
- •Refusal or inability to sign informed consent
研究组 & 干预措施
Arm B
Active Comparator
IC+CCRT
干预措施: IMRT (Radiation)
Arm A
Experimental
IC with anti-PD1 mab+CCRT+anti-PD1 mab
干预措施: Cisplatin (Drug)
Arm A
Experimental
IC with anti-PD1 mab+CCRT+anti-PD1 mab
干预措施: PD-1 antibody (Drug)
Arm A
Experimental
IC with anti-PD1 mab+CCRT+anti-PD1 mab
干预措施: Gemcitabine (Drug)
Arm A
Experimental
IC with anti-PD1 mab+CCRT+anti-PD1 mab
干预措施: IMRT (Radiation)
Arm B
Active Comparator
IC+CCRT
干预措施: Gemcitabine (Drug)
Arm B
Active Comparator
IC+CCRT
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 3 year
From date of randomization to date of first documentation of progression or death due to any cause.
次要结局
- Distant Metastasis-Free Survival (DMFS)(3 year)
- Locoregional Relapse-Free Survival (LRRFS)(3 year)
- Overall Survival (OS)(3 year)
- Objective Response Rate （ORR）(within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy)
- adverse events (AEs)(3 year)
研究者
研究点 (7)
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