Bronchial Arterial Infusion Plus Bronchial Arterial Chemoembolization (BAI-BACE) for Advanced Lung Squamous Cell Carcinoma: a Multicenter Single-arm Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival (PFS)
研究概览
简要总结
Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma.
详细描述
This study is a multicenter, interventional study to explore the efficacy, safety of BAI-BACE as non-first-line therapy for advanced central squamous cell carcinoma. Lung cancer is the leading cause of cancer-related death worldwide. Owing to the insidious symptom, most patients (about 75 %) are diagnosed at the advanced stage of the disease and, thus, cannot undergo resection. The central squamous cell carcinoma accounts for 25% of all cases of lung cancer. The first-line standard treatment for advanced central squamous cell carcinoma is combined chemoradiotherapy, and chemoradiotherapy is usually as the second-line. However, treatment failure is noted in many patients, and those patients often face the limited therapy choice and poor prognosis. Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported to treat lung cancer in many hospitals in China. BAI, which use chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. The systemic toxicity of this surgery is low and tolerable. This study will provide clinical evidence that BACE-BAI will provide survival benefit for patients with advanced central squamous cell carcinoma.
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
- 是
入选标准
- •Squamous cell carcinoma diagnosed by pathology, and central location by imaging;
- •Patients failed to the standard first-line or second-line treatment;
- •Tumors limited in the chest;
- •Tumors were fed by bronchial artery through CTA reconstruction;
- •Patents received PD-1 inhibitor or not were also included;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
- •Images within 2 weeks before inclusion;
- •Life expectancy more than 3 months;
- •Agreed to participated in this clinical trial;
- •Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
排除标准
- •Contraindication of BAI or BACE;
- •Under 18 years or over 75 years;
- •extra-chest metastases;
- •Receiving other antitumor treatment;
- •Severe infection or pregnancy;
- •Severe Pulmonary fibrosis and pulmonary artery;
- •liver, kidney or poor physical conditions;
- •Severe pleural effusion or pericardial effusion;
- •Life expectancy less than 3 months.
结局指标
主要结局
Progression-Free-Survival (PFS)
时间窗: 12 months
Progression was defined as progressive disease by independent radiologic review
次要结局
- Adverse events(24 months)
- Overall survival (OS)(24 months)
- Objective response rate (ORR)(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University