NCT07325214尚未招募不适用
A Randomized, Multicenter, Multiregional, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of IMD10 (Focused Ultrasound) in Combination With the Chemotherapy Regimen Consisting of Irinotecan Hydrochloride, Oxaliplatin, Fluorouracil (5-FU) and Leucovorin Improves Overall Survival Compared With the Chemotherapy Regimen Alone in Patients With Borderline Resectable Pancreatic Cancer or Locally Advanced Pancreatic Cancer
IMGT Co., Ltd.5 个研究点 分布在 2 个国家目标入组 360 人开始时间: 2026年9月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this Interventional clinical trial is to evaluate safety and efficacy of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.
详细描述
- Background: Pancreatic Cancer (PaC) ranks as the 5th most common cause of cancer-related deaths in the Western world. Despite medical advances, PaC continues to have a dismal 5-year survival rate of only 8%. Since the pancreas is in the retroperitoneal cavity, there are few specific symptoms in the early stages, and cancer tissue grows relatively quickly, meaning it is often already advanced at the time of diagnosis.
- Study Design: This is a multinational, randomized, pivotal clinical trial conducted at multiple sites in the United States and the Republic of Korea. Eligible participants will be randomized in a 1:1 ratio to experimental group or control group.
- Interventions: Participants in the experimental group will receive chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] with IMD10.
Participants in the control group will receive chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] alone.
- Outcome Measures: The primary outcome measure is overall survival. Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. For participants still alive at the time of analysis, the OS time is censored on the last date the participants were known to be alive.
- Follow-up: Participants will be followed for safety and survival until the end of study.
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
- Single (Outcomes Assessor)
盲法说明
This clinical trial will be conducted as an open-label study for both investigators and trial participants.
Blinding will be applied only to the independent tumor response evaluator(s) responsible for tumor response assessment of pancreatic adenocarcinoma based on the anonymized CT (or MRI) images that have been uploaded to the central imaging center.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An individual must meet all the following criteria:
- •Willing and able to understand and sign an ICF and to comply with all aspects of the protocol
- •2. Aged between 18 and 85 years, inclusive
- •3. Histologically or cytologically, pathologically confirmed diagnosis of PDAC.
- •4. Classification as BRPC or LAPC according to the NCCN Guidelines (The latest Edition) by radiologic test (CT or MRI), eligible for chemotherapy regimen within 4 weeks of the screening visit
- •5. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit.
- •6. The ECOG performance status 0 or 1
- •7. Trial participant having laboratory values defined as:
- •-- Neutrophil count ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •AST and ALT ≤ 2.5 x ULN
- •Serum creatinine ≤ 1.5 x ULN
- •8. Life expectancy is more than 12 weeks
- •9. A female is eligible to trial participate if not pregnant, not breast feeding -and either a woman not of childbearing potential or, if a woman of childbearing potential agrees to use highly effective methods of contraception from screening to EOS
- •10. A male trial participant with female partner(s) of childbearing potential agrees to use highly effective methods of contraception from screening to EOS
排除标准
- •An individual who meets any of the following criteria will be excluded from participating in this clinical trial:
- •1. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.
- •2. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass
- •3. Targeted tumor(s) is not clearly visible with IMD
- •4. Tumor is not treatable by the working range of IMD10
- •5. Patient has difficulty in lying in supine position.
- •6. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial
- •7. Known, or ongoing receipt at the time of screening, of anti-tumor therapy for pancreatic cancer including chemotherapy, radiation, and/or surgery
- •8. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:
- •Class III or IV heart failure according to New York Heart Association (NYHA) classification
- •Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks --③ Uncontrolled heart arrhythmia
- •Other clinically significant cardiovascular abnormalities as determined by the investigator
- •9. Known history at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:
- •Other uncontrolled chronic infectious diseases
- •Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.)
- •Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia.
- •Clinically significant mental illness
- •10. Known history of malignancies other than pancreatic cancer within the last 2 years
- •11. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)
- •12. Pregnant and breastfeeding women
- •13. Participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1
- •14. Trial participation in the clinical trial is deemed inappropriate at the investigator's discretion, either for ethical reasons or due to potential impact on the clinical trial's outcome
研究组 & 干预措施
Experimental group
Experimental
The experimental group receives IMD10 combined with the chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin].
干预措施: IMD10 (Device)
Experimental group
Experimental
The experimental group receives IMD10 combined with the chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin].
干预措施: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] (Drug)
Control group
Active Comparator
The control group receives the chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] alone, the same regimen administered to the experimental group.
干预措施: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] (Drug)
结局指标
主要结局
Overall Survival
时间窗: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization
次要结局
未报告次要终点
研究者
研究点 (5)
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