Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Two-years disease free survival (2y-DFS)
研究概览
简要总结
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form before starting the study;
- •For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
- •Patients cannot receive targeted adjuvant therapy;
- •18-80 years old;
- •The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
- •The ECOG PS score is 0 or 1;
- •Have not received any chemotherapy for non-small cell lung cancer before enrollment;
- •Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:
- •Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
- •Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
- •Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
- •Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
- •Male patients must agree to use appropriate contraceptive measures.
排除标准
- •Known or suspected to be allergic to the drug or any component of the drug related to the test;
- •Patients who can receive targeted treatment;
- •Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
- •Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
- •Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
- •History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA>1000 copies/ml);
- •The researcher judged that there was a risk of bleeding;
- •Active severe clinical infection (≥ grade 3 CTCAE V5.0);
- •Epilepsy patients who need medication;
- •Allogeneic organ transplantation;
- •Patients who need kidney dialysis;
- •Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
- •Serious uncured wounds, ulcers or fractures;
- •Interstitial pneumonia;
- •Any malabsorption disease;
- •Any disease that is unstable or may endanger the patient's safety;
- •Drug abuse, medical, psychological or social diseases;
- •Participate in other clinical studies within 3 months before enrollment;
- •During pregnancy or lactation;
研究组 & 干预措施
Treatment group
Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity. The chemotherapy regimen is decided by the researcher.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Two-years disease free survival (2y-DFS)
时间窗: Up to approximately 2 years
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.
次要结局
- Five-years disease free survival (5y-DFS)(Up to approximately 5 years)
- Overall survival (OS)(Up to approximately 5 years)
- Five-years overall survival（5y-OS)(Up to approximately 5 years)
- Three-years disease free survival (3y-DFS)(Up to approximately 3 years)
- Disease free survival (DFS）(Up to approximately 2 years)
- Two-years overall survival（2y-OS)(Up to approximately 2 years)
- Three-years overall survival（3y-OS)(Up to approximately 3 years)
- Treatment-related adverse events（TRAE）(Up to approximately 1 year)