NCT06607796招募中3 期
A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer
Zhou Chengzhi1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；
- •Age ≥18 years and ≤75 years at the time of signing the ICF；
- •Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
- •At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；
- •Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；
- •ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
- •Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
- •Life expectancy ≥ 3 months；
- •Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.
排除标准
- •Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
- •Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
- •Have severe bleeding, clotting disorders, infections, dehydration, etc;
- •Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
- •History of severe emphysema and pulmonary alveoli;
- •History of drug allergy or contraindication to toluene sulfonamide;
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- •The investigators determined that the patients had other conditions that made them unsuitable for enrollment.
研究组 & 干预措施
Experimental group
Experimental
intratumoral injection of toluenesulfonamide (PTS) to oligo lesions
干预措施: Toluenesulfonamide (PTS) Intratumoral Injection (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: 3 years
Proportion of target lesions stabilized after two courses of first-line chemoimmunotherapy standard therapy combined with and without PTS intratumoral injection, with tumor volume reduction to achieve complete remission (CR) and partial remission (PR)
次要结局
- Median progression-free survival(mPFS)(3 years)
- Median overall survival(mOS)(3 years)
研究者
Zhou Chengzhi
chief physician
Guangzhou Institute of Respiratory Disease
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)Primary Immune DeficiencyNCT01199705CSL Behring25
招募中
不适用
The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid TumorsIntratumoral InjectionCancerNCT06430515Wuxi People's Hospital200
已完成
3 期
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)Active Systemic Lupus ErythematosusNCT04931563AstraZeneca277
已完成
3 期
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusNCT02446912AstraZeneca460
已完成
3 期
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusNCT02446899AstraZeneca373