NCT04992988Unknown2 期
Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial
Cancer Hospital of Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a prospective, single-arm, phase II trial to study the efficacy of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrence tumor
- •staged as rT3-4N0-1M0 或 rT1-4N2-3M0 （according to the 8th AJCC edition）
- •Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- •Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- •With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
- •With normal renal function test ( creatinine clearance ≥60 ml/min)
- •sign an "informed consent form
- •Male and no pregnant female
排除标准
- •Age> 70, or < 18 years old
- •Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
- •Patients with positive HCV antibody.
- •Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
- •History of interstitial lung disease
- •Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
- •Receive or will receive live vaccine within 30 days prior to signing the informed consent.
- •Women of child-bearing potential who are pregnant or breastfeeding.
- •Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
- •Hypersensitivity to macromolecular protein, or to any component of triplezumab.
- •HIV positive.
- •Severe, uncontrolled medical conditions and infections.
- •Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.
研究组 & 干预措施
Toripalimab+CCRT
Experimental
Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy.
Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 3 weeks after CCRT
干预措施: Toripalimab (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 years
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
次要结局
- Objective Response Rate （ORR）(After the completion of the PD-1 antibody and chemoradiotherapy treatment)
- Incidence rate of adverse events (AEs)(2 years)
- Change of QoL (quality of life)(1 year)
- Progress-free survival (PFS)(2 years)
研究者
Song Qu
Principal Investigator
Cancer Hospital of Guangxi Medical University
研究点 (1)
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