A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 388
- 试验地点
- 6
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.
详细描述
Through multicenter, open-label, randomised clinical trials, high risk patients with nasopharyngeal carcinoma (staged as II-III with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy and staged as IVa) are randomized into camrelizumab plus chemo-radiotherapy arm and chemo-radiotherapy arm. The efficacy and safety of patients between these two arms are compared.
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
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- •Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
- •Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy.
- •Aged between 18-70 years.
- •Karnofsky scale (KPS)≥
- •Normal bone marrow function.
- •Normal liver and kidney function:
- •total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- •creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- •Given written informed consent.
排除标准
- •Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
- •Recurrent or metastatic nasopharyngeal carcinoma.
- •Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.
- •Has known allergy to large molecule protein products or any compound of study therapy.
- •Has known subjects with other malignant tumors.
- •Has any active autoimmune disease or history of autoimmune disease.
- •Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- •The laboratory examination value does not meet the relevant standards within 7 days before enrollment
- •Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
- •Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- •Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- •Has a known history of human immunodeficiency virus (HIV).
- •Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- •Has received a live vaccine within 4 weeks of planned start of study therapy.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Camrelizumab plus chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy.
干预措施: Camrelizumab plus chemo-radiotherapy (Drug)
Chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy.
干预措施: Chemo-radiotherapy alone (Drug)
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 3 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
次要结局
- Incidence of treatment related late complications(up to 3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(up to 3 years)
- Overall Survival (OS)(3 years)
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Locoregional Relapse-Free Survival (LRRFS)(3 years)
- Incidence of treatment related acute complications(up to 1 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(up to 3 years)
研究者
Ming-Yuan Chen
Professor, Chief Doctor
Sun Yat-sen University