Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- progression-free survival
研究概览
简要总结
This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).
详细描述
Widely metastatic nasopharyngeal carcinoma (wmNPC) represented a particular subgroup of patients with the worst prognosis, of which palliative systematic chemotherapy(SC) was recommended as initial treatment, however, palliative systematic treatment was often required to be stopped due to the cumulative toxicities while stopping SC may lead to disease progression, a 'stop and go' approach, namely chemotherapy 'holidays', was a new strategy which may keep a good balance of benefit and risk. This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in wmNPC patients who achieve objective response after SC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator;
- •The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function;
- •Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
- •Able and willing to provide a signed informed consent form, and able to comply with all procedures.
- •The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.
排除标准
- •Patients with a hypersensitivity to any of the drugs used in our study;
- •With any active autoimmune disease or history of autoimmune disease;
- •Clinically significant cardiovascular and cerebrovascular diseases;
- •Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
- •Active systemic infection;
- •Drug or alcohol abuse;
- •No or limited capacity for civil conduct;
- •The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
- •History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；
- •Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
intermittent systematic chemotherapy group
Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
干预措施: Gemcitabine (Drug)
intermittent systematic chemotherapy group
Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
干预措施: Cisplatin (Drug)
intermittent systematic chemotherapy group
Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
干预措施: Paclitaxel protein-bound (Drug)
intermittent systematic chemotherapy group
Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
干预措施: Capecitabine (Drug)
intermittent systematic chemotherapy group
Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
progression-free survival
时间窗: 1 year
the time interval from the start of chemotherapy to the date of progression
次要结局
- progression-free survival 2(1 year)
- overall survival(1 year)