NCT04453813招募中3 期
A Multicenter Randomized Clinical Phase 3 Trial of Toripalimab Plus Concurrent Chemo-radiotherapy vs Concurrent Chemo-radiotherapy Alone for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Sun Yat-sen University6 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2020年7月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 6
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.
详细描述
Through multicenter, open-label, randomised clinical trials, patients with unresectable locally recurrent nasopharyngeal carcinoma are randomized into concurrent chemo-radiotherapy plus concurrent and adjuvant PD-1 treatment group and concurrent chemo-radiotherapy alone group. The efficacy and safety of patients between these two groups are compared.
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
- •Histologically confirmed recurrent nasopharyngeal carcinoma.
- •The recurrence time is more than 12 months from the end of the first course of radiotherapy.
- •Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
- •Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
- •Karnofsky scale (KPS)≥
- •Normal bone marrow function.
- •Normal liver and kidney function:
- •total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- •creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- •Given written informed consent.
排除标准
- •Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the sphenoid sinus and is more than 0.5cm from the internal carotid artery and cavernous sinus).
- •The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers.
- •Has known allergy to large molecule protein products or any compound of study therapy.
- •Has known subjects with other malignant tumors.
- •Has any active autoimmune disease or history of autoimmune disease.
- •Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- •The laboratory examination value does not meet the relevant standards within 7 days before enrollment
- •Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
- •Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- •Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- •Has a known history of human immunodeficiency virus (HIV).
- •Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive
- •Has received a live vaccine within 4 weeks of planned start of study therapy
- •Pregnancy or breast feeding
研究组 & 干预措施
Toripalimab plus concurrent chemo-radiotherapy arm
Experimental
Concurrent chemo-radiotherapy plus concurrent and adjuvant toripalimab.
干预措施: Toripalimab plus concurrent chemo-radiotherapy (Drug)
Concurrent chemo-radiotherapy arm
Active Comparator
Concurrent chemo-radiotherapy alone.
干预措施: Concurrent chemo-radiotherapy (Drug)
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 3 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
次要结局
- Overall Survival (OS)(3 years)
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Locoregional Relapse-Free Survival (LRRFS)(3 years)
- Incidence of treatment related acute complications(up to 1 years)
- Incidence of treatment related late complications(up to 3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(up to 3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(up to 3 years)
研究者
Ming-Yuan Chen
Professor, Chief Doctor
Sun Yat-sen University
研究点 (6)
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