A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1.
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.
详细描述
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will receive ACT treatment (the drug PS101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified FOLFIRINOX chemotherapy.
ACT treatment will be given on Day 1 of each cycle of chemotherapy. Patients' well-being and side effects will be assessed at the same visits. The objective efficacy of the treatment will be assessed by CT scans every 8 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
- •Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.
排除标准
- •Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
研究组 & 干预措施
Acoustic Cluster Therapy (ACT) with mFOLFIRINOX
干预措施: Acoustic Cluster Therapy (Combination Product)
Acoustic Cluster Therapy (ACT) with mFOLFIRINOX
干预措施: Modified FOLFIRINOX (Drug)
结局指标
主要结局
ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1.
时间窗: From baseline to end of treatment (up to Week 24)
次要结局
- Overall summary of TEAEs including number and percentage of participants with at least one TEAE. TEAEs will be summarized by System Organ Class and Preferred Term. TEAEs will be summarized by severity and causality.(From enrollment up to week 24)
- Change in maximum tumor diameter and volume summarized as the largest or the smallest percentage change from baseline. Independent central image review based on RECIST 1.1 criteria will be the primary analysis.(From baseline up to week 24)
- Median OS and proportion of participants alive at 6 months.(from baseline to week 24)
- The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review(from baseline to week 24)