A Single-armed Phase Ⅱ Study of Bevacizumab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Lung Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma
详细描述
This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma.
All patients received 4 cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks for up to 1 year. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (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 lung adenocarcinoma
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Unresectable, refusing surgery or after R2 surgery ,confirmed by PET-CT or chest and abdominal CT, craniocerebral MRI, and ECT.
- •After radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable.
- •1-2 months after chemoradiotherapy ends.
- •Organ and bone marrow functions were normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm
- •CB6 within normal limits
- •Patients and their family signed the informed consents
排除标准
- •Lung squamous carcinoma.
- •The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).
- •The tumor was associated with a cavity over 2cm in diameter.
- •Bleeding tendency or coagulation disorder.
- •Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.
- •Full-dose anticoagulation therapy was used within the past 1 month.
- •Severe vascular disease occurred within 6 months.
- •Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.
- •Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.
- •Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).
- •Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
- •Urine protein 3-4+, or 24h urine protein quantitative >1g.
- •Degree 3 esophagitis after chemoradiotherapy has not recovered.
- •Elderly patients (age 75 years).
- •The investigator does not consider the participant to be eligible for this study.
研究组 & 干预措施
Bevacizumab
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, with one-month break.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
干预措施: Bevacizumab (Drug)
Bevacizumab
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, with one-month break.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
干预措施: chest radiation (Radiation)
Bevacizumab
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, with one-month break.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
干预措施: concurrent chemotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3-year
Progression-free survival in patients
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
时间窗: 1 year from the end of chemoradiotherapy
radiation-induced pulmonary injury is classified into 1-5 grades according to NCI-CTC4.0. The incidence of symptomatic radiation-induced pulmonary injury: the ratio of grade 2 and above radiation-induced pulmonary injury cases in 1 year after radio therapy to all cases can be evaluated .
次要结局
- response rate(3-year)
- rate of grade 3-4 radiation esophagitis(3-year)
- rate of grade 3-4 radiation pneumonitis(3-year)
- overall survival(3-year)
研究者
Hui Liu
Professor
Sun Yat-sen University