NCT03448146已完成3 期
A Phase III Single Arm Trial of PTS (Para Toluenesulfonamide Injection) Via Bronchoscopy Intervention Intratumoral Injection in Patients With Central Air Way NSCLC Tumor Severe Obstruction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction.
详细描述
- Local intratumoral injection of para toluenesulfonamide (PTS) via bronchoscopy could alleviate airway obstruction for patients with central air way NSCLC tumor severe obstruction, which contributed to the shrinkage of target tumor lesions in a short period, with an objective response rate of 66% and an improvement rate of luminal tumor obstruction of 70% in the end-of-treatment period.
- Patient's pulmonary function, atelectasis and quality of life were improved significantly after treatment, indicating that PTS treatment cuold relieve the symptoms of air way obstruction and provide clinical benefits to the patients.
- Adverse events were mainly blood streaked sputum, injection site haemorrhage, cough, pyrexia and oropharyngeal pain, without reporting of potential risks. Common study drug related adverse events included injection site haemorrhage, cough, and blood streaked sputum and oropharyngeal pain. The multi-center clinical study conducted strictly in accordance with Standard Operation Procedures for the Use of a Standard Bronchoscope in Local Intratumoral PTS Injection showed that PTS had good safety and tolerability and that the procedural risks of intratumoral PTS injection via bronchoscopy could be controlled.
- The advantages of PTS for treatment of airway lung cancer obstruction included significant efficacy, good safety, large applicable population; relatively simple equipment conditions and operation, thus it could be spread easily. PTS is also expected to be used in the treatment of central lung cancer with acute airway obstruction in combination with other treatments (such as stent implantation), which provides a new drug treatment to patients with airway lung cancer obstruction. PTS can complement with other treatments, which is expected to improve the treatment efficacy significantly.
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 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female inpatients, aged 18 to 83 years old.
- •Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: ≥1/2 trachea is obstructed by tumor; and/or block ≥2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion > 0.5 cm.
- •Pathologically confirmed lung cancer.
- •Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy.
- •At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors.
- •Blood platelet count ≥ 100,000/mm
- •Subjects who were able to understand and comply with the trial protocol and give written consent.
排除标准
- •Brain metastases.
- •History of cardiovascular diseases, including congestive heart failure > New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded.
- •Severe infections or dysbolism.
- •Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators.
- •Poor general conditions or cachexia.
- •The target lesion had been treated with radiotherapy within 6 months.
- •Pregnant or breast-feeding woman.
- •Known hypersensitivity to PTS or related compounds.
- •Lung cancer lesions not suitable for local treatment.
- •Any other reason deemed reasonable by the investigator.
研究组 & 干预措施
Para-Toluenesulfonamide
Experimental
- .The dose of PTS injected into multiple points in a single tumor was about 0.1-1.0 mL, and the appropriate specific doses were kept within the tumor without leakage. An appropriate low dose could be given firstly, and the following doses could be adjusted based on the response of patient and the tumor.
- . In general, the daily dose of PTS injected into a single tumor was no more than 5mL, and the daily dose of PTS was no more than 10mL for each patient.
The injection was provided 2-3 times a week, with 2 weeks as a cycle of treatment. No less than 4 times of PTS treatment were recomended for the first cycle of treatment, and for other cycles of treatment, the number of PTS injections could be adjusted appropriately based on the condition of the patient.
干预措施: Para-Toluenesulfonamide (Drug)
结局指标
主要结局
Objective response rate
时间窗: 30 days after the last treatment
The objective response rate of target lesions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.
Improvement rate of luminal obstructions
时间窗: 30 days after the last treatment
The improvement rate of luminal obstructions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.
次要结局
- Change in BDI score(30 days after the last treatment)
- Change in FVC(30 days after the last treatment)
- Change in FEV1/FVC(30 days after the last treatment)
- Change in pleural effusion(30 days after the last treatment)
- Change in ECOG performance status(30 days after the last treatment)
- Change in QOL score(30 days after the last treatment)
- Duration of response (DOR) of target lesion(30 days after the last treatment)
研究者
研究点 (1)
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