Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) . Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
详细描述
The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) locoregionally advanced nasopharyngeal carcinoma (LANPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab (200mg q3wk), and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. IMRT：PGTVnx: 69.96 Gy /33f, PGTVnd: 66~70 Gy /33f, PCTVnd: 63~64 Gy/33f, PCTV1: 60~62 Gy/33f, PCTV2: 54~56 Gy/33f. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 histologically confirmed Non-keratinizing nasopharyngeal carcinoma.
- •Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0).
- •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
- •1.Age > 70 or <
- •2.Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml 3.Hepatitis C virus (HCV) antibody positive 4.Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment.
- •5.Has a known history of interstitial lung disease. 6.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.
- •7.Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
- •8.Is pregnant or breastfeeding. 9.Has a history of other malignancies except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.
- •10.Has known allergy to large molecule protein products or any compound of sintilimab.
- •11.Has a known history of human immunodeficiency virus (HIV) infection. 12.Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a
研究组 & 干预措施
Sintilimab+Chemoradiotherapy
Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
干预措施: Sintilimab (PD-1 Antibody) (Drug)
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 5 years
Defined from date of recruit to date of first documentation of progression or death due to any cause.
次要结局
- Locoregional Relapse-Free Survival (LRRFS)(5 years)
- Overall Survival (OS)(5 years)
- Distant Metastasis-Free Survival (DMFS)(5 years)
- Objective Response Rate （ORR）(through study completion, an average of 1 year)
- Incidence rate of adverse events (AEs)(5 years)
- Serious adverse events (SAE)(5 years)
研究者
Xiaodong Zhu
Principal Investigator
Cancer Hospital of Guangxi Medical University