NCT07649369尚未招募2 期
A Randomized, Controlled, Double-Blind, Multi-center Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion
Shanghai Jeyou Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Puncture/drainage - Free Survival (PuFS)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- •Moderate to large pleural effusions require intervention.
- •ECOG performance status: 0 to
- •Life expectancy ≥ 3 months
- •Adequate organ function.
- •The serum pregnancy test of female participants of childbearing potential should be negative within 7 days prior to enrollment and must not be breastfeeding. With a fertile female/male must agree to use medically accepted non-pharmacological contraception during the study and for 6 months after the last dose.
排除标准
- •Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- •Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- •Known allergies to the study drug or its excipient components.
- •Have participated in other clinical trials within 28 days prior to randomization.
- •Major surgery within 28 days prior to randomization.
- •Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
- •Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
- •Active infections that require systemic treatment.
- •Have a history of organ transplantation.
- •Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
研究组 & 干预措施
Arm A
Experimental
JMKX000197
干预措施: JMKX000197 (Drug)
Arm B
Experimental
JMKX000197
干预措施: JMKX000197 (Drug)
Arm C
Active Comparator
Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Puncture/drainage - Free Survival (PuFS)
时间窗: From the date of chest tube removal after the last dose of treatment until the date of next puncture /drainage or date of death from any cause, whichever come first, up to approximately 24 months
次要结局
- Pleural effusion overall response (ORR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
- AEs or SAEs(Up to approximately 29 days)
研究者
研究点 (1)
Loading locations...
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