NCT06718309招募中2 期
A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer
First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
- •Age ≥18 years;
- •(Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
- •According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor > 7cm);
- •Puncture or biopsy samples were tested EGFR/ALK negative;
- •Surgically or potentially resectable after discussion by multidisciplinary team (MDT);
- •Who has not received systemic antitumor therapy and has not received chest radiotherapy;
- •Evaluable lesions in the lung or mediastinum;
- •The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0*10^9/L or neutrophil count ≥1.5*10^9/L, platelet count ≥100*10^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level > 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level < 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
- •Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
- •Sign informed consent.
排除标准
- •Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
- •Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
- •Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
- •Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
- •Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
- •Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
- •Patients who are allergic or contraindicated to PD-1 inhibitors.
研究组 & 干预措施
Treatment group
Experimental
Treatment group
干预措施: Chemotherapy (Drug)
Treatment group
Experimental
Treatment group
干预措施: Immunotherapy (Drug)
Treatment group
Experimental
Treatment group
干预措施: Radical resection of lung cancer (Procedure)
Treatment group
Experimental
Treatment group
干预措施: SBRT (Radiation)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: Assessed up to 24 weeks
Pathological complete response for surgical patients
次要结局
- Major pathologic response (MPR)(Assessed up to 24 weeks)
- 1-year event-free survival (1 year EFS)(Assessed up to 100 months)
- The R0 resection rate(Assessed up to 24 weeks)
- Incidence of treatment-related adverse events(assessed up to 100 months)
研究者
研究点 (1)
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