A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
研究概览
简要总结
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.
详细描述
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor.
All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of NSCLC.
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI.
- •Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Previously treated with chemotherapy or treatment-naive
- •No previous chest radiotherapy, immunotherapy or biotherapy
- •Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- •Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- •Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- •FEV1 >0.8 L
- •CB6 within normal limits
- •patients and their family signed the informed consents
排除标准
- •Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- •Contraindication for chemotherapy
- •Malignant pleural or pericardial effusion.
- •Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- •Women who has the probability of pregnancy without contraception
- •Tendency of hemorrhage
- •In other clinical trials within 30 days
- •Addicted in drugs or alcohol, AIDS patients
- •Uncontrollable seizure or psychotic patients without self-control ability
- •Severe allergy or idiosyncrasy
- •Not suitable for this study judged by researchers
研究组 & 干预措施
Thymosin α1
Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
干预措施: Concurrent chemotherapy (Drug)
Thymosin α1
Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
干预措施: split-course radiotherapy (Radiation)
Thymosin α1
Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
干预措施: thymosin alpha 1 (Drug)
结局指标
主要结局
Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
时间窗: 1-year
Radiation-induced pneumonitis except other reasons induced pneumonia
次要结局
- Total lymphocyte count(From the beginning of CCRT until 6 months after the completion of CCRT.)
- C-reaction protein(From the beginning of CCRT until 6 months after the completion of CCRT.)
- grade of pulmonary fibrosis (CTCAE 5.0 version)(1-year)
研究者
Hui Liu
Professor
Sun Yat-sen University