NCT05340491招募中3 期
Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Sun Yat-sen University12 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 12
- 主要终点
- Overall survival
研究概览
简要总结
This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;
- •Not suitable for surgery;
- •Histologic diagnosis of NPC (WHO II/III);
- •TNM stage rII-IVa (AJCC/UICC 8th);
- •ECOG 0-1 point;
- •No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- •No contraindications to immunotherapy or chemoradiotherapy;
- •Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
- •Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- •Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- •Take effective contraceptions during and two months after treatment;
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •Treated with anti-tumor Chinese medicine treatment;
- •Have recurrence with local necrosis;
- •Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- •Unexplained fever > 38.5, except for tumor fever;
- •Treated with ≥ 5 days antibiotics one month before enrollment;
- •Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
- •Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
- •Have known allergy to large molecule protein products or any compound of study therapy;
- •Pregnant or breastfeeding;
- •Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- •Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- •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
Chemoradiotherapy
Active Comparator
Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.
干预措施: Intensity modulated radiotherapy (Radiation)
Chemoradiotherapy
Active Comparator
Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.
干预措施: Chemotherapy (Drug)
Chemoradiotherapy+anti-PD-1
Experimental
Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: Chemotherapy (Drug)
Chemoradiotherapy+anti-PD-1
Experimental
Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: Intensity modulated radiotherapy (Radiation)
Chemoradiotherapy+anti-PD-1
Experimental
Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Overall survival
时间窗: three years
Defined as the time from date of recruitment to death from any cause.
次要结局
- Disease control rate through study completion, an average of nine months(through study completion, an average of nine months)
- Late toxicity(three years)
- Failure-free survival(three years)
- Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years(up to three-year follow-up)
- Objective response rate through study completion, an average of nine months(through study completion, an average of nine months)
- Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)(through study completion, an average of nine months)
- Quality of life through study completion, up to 3 years(up to three-year follow-up)
研究者
Zhao Chong
Prof.
Sun Yat-sen University
研究点 (12)
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