Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-maintenance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.
详细描述
Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years old.
- •Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- •ECOG PS was 0 or
- •Adequate organ and bone marrow function is present. Absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization.
排除标准
- •History of allogeneic organ transplantation.
- •Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [Colitis or Crohn's disease], diverticulitis [other than diverticulitis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis]).
- •There is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease.
- •History of another primary malignancy.
- •History of active primary immunodeficiency.
- •Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
- •For any unmitigated toxicity during pre-study chemoradiotherapy. Patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician.
- •Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.
- •Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.
研究组 & 干预措施
Oral vinorelbine concurrent radiotherapy group
All patients with unresectable stage III non-small cell lung cancer who received neoadjuvant chemo-immunotherapy received oral vinorelbine (60mg per square meter of body-surface area every 2 weeks before radiotherapy, and 30mg per square meter of body-surface area per week during radiotherapy) as radical concurrent chemoratherapy.
干预措施: vinorelbine (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 years
The time between the start of treatment and death from any cause in the one-arm trial
objective response rate
时间窗: 3 months
The ratio of complete response and partial response at 3 months after the end of radiotherapy
次要结局
未报告次要终点