Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as recurrence/metastatic NPC
- •Histopathological diagnosis of NPC(WHO II/III)
- •ECOG 0-1 point
- •No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- •No contraindications to immunotherapy and chemoradiotherapy;
- •At least one lesion could receive SBRT safely;
- •Subject must have a measurable target lesion based on RECIST v1.1;
- •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 three months after treatment;
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
- •Unexplained fever > 38.5 #, except for tumor fever;
- •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 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
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: SBRT (Radiation)
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: Low-dose Radiotherapy (LDRT) (Radiation)
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: IMRT (Radiation)
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: Toripalimab (Drug)
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: Gemcitabine (Drug)
SBRT+LDRT+PD-1+Chemotherapy
Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to 12 months
Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate(up to 12 months)
- Overall Survival(up to 12 months)
- Disease Control Rate(up to 12 months)
- Adverse Events(up to 12 months)
- QoL(up to 12 months)
研究者
Zhao Chong
Dr. Prof.
Sun Yat-sen University