NCT06820762尚未招募2 期
Irinotecan Liposome(II) Combined with Ivonescimab As Second-line Treatment for Small Cell Lung Cancer : a Prospective, Single-arm, Multicenter Clinical Study
The Second Affiliated Hospital of Dalian Medical University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月28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
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.
详细描述
This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.
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
- •Age ≥18 years;
- •Histologically or cytologically confirmed SCLC;
- •Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
- •The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- •Life expectancy of ≥3 months;
- •At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）
- •No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment
- •Have adequate organ function;
- •All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.
- •Able and willing to provide a written informed consent;
排除标准
- •Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients
- •History of severe active autoimmune disease
- •Participated in other drug studies within 4 weeks before enrollment
- •Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk
- •History of major illness within 1 year before the first medication
- •History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration
- •History of surgery or severe trauma within 4 weeks prior to initial dosing
- •Evidence and history of severe bleeding tendency;
- •Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment
- •Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.
研究组 & 干预措施
Experimental: Irinotecan liposome (II) combined with ivonescimab
Experimental
Subjects will be administered with irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity
干预措施: irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Up to approximately 2 years
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
次要结局
- Objective response rate（ORR）(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Treatment related adverse events (TRAEs)(Up to 30 days after last treatment)
研究者
研究点 (2)
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