Spatially Fractionated Radiotherapy (SFRT) Synchronized With Tislelizumab Plus Platinum-based Dual-agent Chemotherapy for Induction Treatment of Initially Unresectable Stage Ⅲ Non-small Cell Lung Cancer: A Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surgical resection rate
研究概览
简要总结
The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are:
Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?
详细描述
Research Title: A Clinical Study on Induction Treatment with Spatial Fractionated Radiotherapy (SFRT) Concurrent with Tislelizumab Plus Platinum-based Doublet Chemotherapy for Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Research Objective: To explore the efficacy and safety of induction treatment with spatial fractionated radiotherapy (SFRT) concurrent with tislelizumab plus platinum-based doublet chemotherapy for initially unresectable stage III non-small cell lung cancer (NSCLC).
Design Type: Interventional Study Research Subjects: Patients with non-small cell lung cancer diagnosed by pathological histology or cytology, staged as stage III (T3 - 4N1 - 2M0) according to the 8th edition of AJCC, defined as initially unresectable by the multidisciplinary team (MDT), without known EGFR and ALK mutations, aged ≥ 18 years old, with an ECOG PS score of 0 - 1.
Sample Size: 30 cases
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC).
排除标准
- •Has participated in another clinical study using research products within the past 3 weeks.
研究组 & 干预措施
SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy
SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details:
Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect.
Chemotherapy & Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).
干预措施: Spatially Fractionated Radiotherapy (SFRT) (Other)
SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy
SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details:
Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect.
Chemotherapy & Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).
干预措施: Tislelizumab, paclitaxel, Carboplatin (Drug)
SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy
SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details:
Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect.
Chemotherapy & Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).
干预措施: Tislelizumab, Carboplatin, Pemetrexed (Drug)
结局指标
主要结局
Surgical resection rate
时间窗: At the end of the surgery
The percentage of patients who underwent surgical resection after induction treatment
次要结局
未报告次要终点