Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma
详细描述
This is a prospective phase II study that enrolled patients with previously untreated de novo metastatic nasopharyngeal carcinoma who achieved either a complete response (CR) or partial response (PR) after 4-6 cycles of treatment with gemcitabine plus cisplatin (GP regimen) chemotherapy combined with tislelizumab. Based on tumor response stratification, these patients received locoregional radiotherapy and radiotherapy for metastatic lesions, followed by sequential tislelizumab maintenance therapy.
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
- •Age 18-70 years.
- •Newly diagnosed nasopharyngeal carcinoma with pathological confirmation of non-keratinizing carcinoma (WHO type II or III).
- •Stage IV (T1-4N0-3M1a and M1b) according to the AJCC/UICC 9th edition clinical staging system for NPC.
- •Achieved complete response (CR) or partial response (PR) by imaging evaluation after 4-6 cycles of GP chemotherapy combined with tislelizumab.
- •ECOG performance status: 0-
- •Adequate organ function.
排除标准
- •Recurrent or metastatic nasopharyngeal carcinoma after radical treatment.
- •Other malignancies diagnosed or treated within the past 5 years (except basal cell carcinoma, cervical carcinoma in situ, and superficial bladder tumors).
- •Previous treatment with immune checkpoint inhibitors.
- •Pregnancy or lactation (consider pregnancy testing for women of childbearing age and emphasize effective contraception during treatment).
- •Active or history of autoimmune diseases.
- •Concurrent medical condition requiring the use of immunosuppressive medications.
- •Active hepatitis B or C infection.
研究组 & 干预措施
response-adapted radiotherapy
This is a prospective phase II study that enrolled patients with previously untreated de novo metastatic nasopharyngeal carcinoma who achieved either a complete response (CR) or partial response (PR) after 4-6 cycles of treatment with gemcitabine plus cisplatin (GP regimen) chemotherapy combined with tislelizumab. Based on tumor response stratification, these patients received locoregional radiotherapy and radiotherapy for metastatic lesions, followed by sequential tislelizumab maintenance therapy.
干预措施: response-adapted radiotherapy (Radiation)
结局指标
主要结局
PFS
时间窗: 1-year
PFS is defined as the time from the initiation of treatment until the first occurrence of locoregional progression, distant metastatic progression, or death from any cause, whichever comes first.
次要结局
- ORR(1-year)
- OS(1-year)
- Local Regional Control(1-year)
- Distant Metastasis Control(1-year)
- DoR(1-year)
研究者
Xin Zhang
Associate Chief Physician
Chongqing University Cancer Hospital