3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 8
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.
详细描述
Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years
- •Cytologically or histologically confirmed pancreatic adenocarcinoma
- •Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)
- •Single tumor size≤ 6 cm
- •Karnofsky performance score （KPS）≥60
- •Estimated survival ≥3 months
- •Without other several comorbidity
- •Participants must have adequate organ function:
- •WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L
- •Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal
- •Albumin≥3g/dL
- •Total bilirubin ≤3mg/dL
- •PT≤3 × institutional upper limit of normal or INR≤2.3
- •Creatinine ≤1.5 × institutional upper limit of normal
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with other malignant tumors
- •History of other anti-cancer therapy, including surgery,radiation, ablation and so on
- •Pregnant or lactating women
- •Patients with Immunodeficiency disease
- •Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
- •Uncontrolled hypertension
- •Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)
- •Active tuberculosis
- •Chronic renal insufficiency
- •Other organ failure
- •History of organ transplantation
- •History of severe mental illness
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 24 months
ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
次要结局
- Incidence of treatment-emergent toxicities of two treatment regimens in patients(24 months)
- Overall Survival (OS)(24 months)
- Quality of life of two treatment regimens in patients(24 months)
研究者
Zhongmin Wang
Principal Investigator
Ruijin Hospital