NCT05789043招募中3 期
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年3月21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
- 140
- 试验地点
- 1
- 主要终点
- Progression Free Survival, PFS
研究概览
简要总结
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:≥18 years, male or female.
- •Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
- •Has not received any systematic anti-tumor drug treatment.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Adequate organ function.
- •Life expectancy of greater than 12 weeks.
- •Patient has given written informed consent.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
- •Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Received a live vaccine within 4 weeks before the first dose of study medication.
- •Pregnancy or breast feeding.
- •Decision of unsuitableness by principal investigator or physician-in charge.
研究组 & 干预措施
Two-drug arm
Active Comparator
干预措施: camrelizumab+apatinib (Drug)
Three-drug arm
Experimental
干预措施: camrelizumab+apatinib+TMZ (Drug)
single-drug arm
Active Comparator
干预措施: camrelizumab (Drug)
结局指标
主要结局
Progression Free Survival, PFS
时间窗: Within 2 years
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
次要结局
- ORR(Within 2 years)
- Overall Survival ,OS(Within 2 years)
- Adverse Events (AEs)(Within 2 years)
- DCR(Within 2 years)
研究者
Jun Guo
Chief physician
Peking University Cancer Hospital & Institute
研究点 (1)
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