PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial
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, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody 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 recurrence ± regional recurrence after ≥1 year of radical treatment;
- •Not suitable for surgery;
- •Newly histologic diagnosis of NPC (WHO II/III);
- •Clinical stage rII-IVa (AJCC/UICC 8th);
- •ECOG 0-1 point;
- •No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- •No contraindications to immunotherapy or radiotherapy;
- •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 ≥10E4copiers/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
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
干预措施: GP (Drug)
Chemoradiotherapy
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
干预措施: IMRT (Radiation)
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: PD-1 blocking antibody (Drug)
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: GP (Drug)
PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
干预措施: IMRT (Radiation)
结局指标
主要结局
Overall survival
时间窗: 3 years
From date of randomisation to death
次要结局
- Progression free survival(3 years)
- Short-term effects(through study completion, an average of 2 months)
- Rate of patients with acute toxicities(through study completion, an average of 2 months)
- Quality of life: EuroQoL 5 dimension(through whole study, an average of 3 years)
研究者
Zhao Chong
Prof.
Sun Yat-sen University