NCT04870905尚未招募2 期
Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: a Phase 2 Trial
Affiliated Cancer Hospital & Institute of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Failure-free survival (FFS)
研究概览
简要总结
This trial intends to enroll patients with T4N1 or T1-4N2-3 (AJCC 8th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). All the Patients will receive 3 cycles of induction chemotherapy with docetaxel and cisplatin and cisplatin based concurrent chemoradiotherapy (CCRT) plus adjuvant immunotherapy (tisleilizumab). All patients will receive intensity-modulated radiotherapy (IMRT). Tisleilizumab will begin 4-6 weeks after CCRT and continue every 3 weeks for 12 cycles.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed nasopharyngeal carcinoma. Stage T4N1 or T1-4N2-3 (AJCC 8th). Eastern Cooperative Oncology Group performance status ≤
- •Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- •Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
- •Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
- •Patients must be informed of the investigational nature of this study and give written informed consent.
- •Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
排除标准
- •Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml;Hepatitis C virus (HCV) antibody positive Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
- •Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
- •Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
- •Has a known history of interstitial lung disease. Heart disease that is not well controlled,including symptomatic heart failure, unstable angina, myocardial infarction.
- •Is pregnant or breastfeeding. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
- •Has known allergy to large molecule protein products or any compound of tisleilizumab.
- •Has a known history of human immunodeficiency virus (HIV) infection. Active infection requiring systemic therapy. A history of psychotropic substance abuse, alcohol or drug abuse Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
研究组 & 干预措施
ICRT arm
Experimental
干预措施: Tis-U-Sol (Drug)
结局指标
主要结局
Failure-free survival (FFS)
时间窗: 3 years
From randomization to the date of locoregional failure, distant failure, or death from any cause.
次要结局
未报告次要终点
研究者
Yuan yawei
Professor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical CancerCervical CancerNeoadjuvant ChemoimmunotherapyFertility PreservationNCT06289062Tongji Hospital40
招募中
2 期
Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal TypeLymphomaNCT05477264Won Seog Kim38
招募中
不适用
Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal CarcinomaSintilimabNasopharyngeal CarcinomaNCT05707819Cancer Hospital of Guangxi Medical University43
招募中
3 期
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal CancerRectal NeoplasmsNCT06017583Yong Zhang,MD48
进行中（未招募）
3 期
Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal CarcinomaNasopharyngeal NeoplasmsNCT03700476Sun Yat-sen University425