NCT04814069Unknown2 期
A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 个研究点目标入组 38 人开始时间: 2021年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 38
- 主要终点
- 1-year disease free survival
研究概览
简要总结
To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.
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
- •Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx
- •With at least one high risk factor after radical surgery ①positive margin; ②close margin（<5mm); ③ENE.
- •No distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •ECOG PS 0-1
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 80 * 10^9/l Hemoglobin >= 80 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >30 ml/min
- •Signed written informed consent
排除标准
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- •Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
结局指标
主要结局
1-year disease free survival
时间窗: 1 year
from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause
次要结局
- Overall survival(2 years)
- Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment(up to 3 months after completion of radiotherapy)
研究者
Guopei Zhu
Dr.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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