Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
详细描述
Nasopharyngeal carcinoma (NPC) is endemic in southern China, southeast Asia, and northern Africa. According to a survey from the International Agency for Research on Cancer, there were an estimated 129,079 new cases and 72,987 related deaths in 2018. Radiotherapy is the primary treatment option. Due to advances in disease management, diagnostic imaging, radiotherapy technology, and the broader application of systemic therapy, the prognosis of NPC has improved signifificantly.Nevertheless, localregional recurrence will occur in about 10% patients. Because of radiation resistance, the prognosis of re-irradiation is poor for recurrent nasopharyngeal carcinoma.
Hence, there is an urgent need for novel therapies to improve survival and reduce treatment-related toxicity in recurrent NPC patients. Emerging evidence shows that PD-1 antibody is effective for treating recurrent/metastastic NPC patients. This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with concurrent chemoradiotherapy (CCRT) versus CCRT alone in treating patients with locoregionally recurrent 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 65 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 recurrent 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 older than 65, or younger than 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
Toripalimab 240mg, and Cisplatin 100mg/m2 (every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT), followed by Toripalimab 240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy.
IMRT: total dose 60-66Gy, 1.8-2.0Gy/f
干预措施: Toripalimab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 5 years
Defined from date of randomization to date of first documentation of death from 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)(3 months)
- Progress-free survival (PFS)(5 years)
- Incidence rate of adverse events (AEs)(5 years)
- Change of QoL (quality of life)(1 year)
研究者
Song Qu
Principal Investigator
Cancer Hospital of Guangxi Medical University