NCT06524518尚未招募2 期
Xuanwu Hospital Capital Medical University
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old
- •gender: men and women can be balanced as far as possible
- •Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
- •no previous exposure to immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 And anti-PD-L2 antibodies
- •ECOG behavior status score 0 ~ 1
- •EGFR or ALK driver gene mutation negative
- •organ function level meets the conditions: 1) Hematological examination indicators: absolute neutrophil count (ANC) ≥1.8×109/L, platelet count ≥ 100×109/L, hemoglobin ≥9 g/dL.
- •Appropriate liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN), aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤2.5×ULN 3) Appropriate renal function: serum creatinine ≤1.25×ULN, or creatinine clearance ≥60 mL/min
- •Sign informed consent
排除标准
- •Any other anti-tumor treatment before surgery
- •Patients with previous history of other malignant tumors
- •Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
- •CT scan at baseline revealed idiopathic pulmonary fibrosis.
- •Pregnant or lactating women
- •multiple lung cancer patients
- •Patient's organ system status:
- •Prior interstitial lung disease, drug-induced interstitial disease, radiation pneumonia or REN requiring hormone therapy Any clinical evidence of active interstitial lung disease 2) In the investigator's judgment, there is a severe or uncontrollable systemic disease (e.g. unstable or uncompensable) Evidence of respiratory, heart, liver or kidney disease) 3) Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, Congestive heart failure, liver, kidney or metabolic disease) 4) Can not accept oral administration, need intravenous high energy nutrition, prior surgery affecting absorption or live Patients with dynamic peptic ulcer
- •Functional level of patients with various organ lesions:
- •Bone marrow: absolute neutrophil count (ANC) < 1.5×109/L, platelets < 90×109/L or blood V1.1 2024.5.29 Albumin < 9 g/dl
- •Liver: serum bilirubin > 1.5 times the upper limit of normal
- •Serum creatinine > 1.25 times the normal value
- •any other disease, neurological or metabolic disorder, the evidence of physical examination or laboratory test results is reasonable Suspected illness or presence of counterindications of use of related drugs or placing subjects at high levels of treatment-related complications The possibility of risk.
- •No R0 resection [ananatomical lobectomy/total pulmonary resection + systemic lymph node dissection (including at least 3 groups of N1) And 3 groups of N2 lymph nodes), both gross and microscopic incisal margins were negative].
- •Situations considered unsuitable for inclusion by other researchers
研究组 & 干预措施
MRD-negative follow-up
Sham Comparator
干预措施: Chemotherapy combined with immunization (Drug)
MRD-positive adaptive therapy
Experimental
干预措施: Chemotherapy combined with immunization (Drug)
结局指标
主要结局
DFS
时间窗: MRD-positive patients were treated 3 years after intervention
3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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