Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally Advanced Pancreatic Adenocarcinoma: EF-54/PANOVA-3CA
试验速览
- 阶段
- 不适用
- 状态
- Temporarily Not Available
研究概览
简要总结
The EF-54 program (PANOVA-3CA) is a continued access program for adults with locally advanced pancreatic cancer to access TTFields therapy in combination with gemcitabine and nab-paclitaxel. The purpose of the program is to allow eligible patients to have access to TTFields while the NovoTTF-200T system is under FDA review. Safety and device performance will be monitored during routine clinical care.
详细描述
This is a non-comparative continued access program. All enrolled patients who meet eligibility criteria will receive TTFields with gemcitabine and nab-paclitaxel.
Eligible patients are ≥22 years old, have histologically or cytologically confirmed de novo pancreatic adenocarcinoma not amenable to surgical resection and without evidence of distant metastases, an ECOG performance status of 0-2, and are candidates for gemcitabine plus nab-paclitaxel chemotherapy.
Patients will continue TTFields therapy in combination with chemotherapy according to the treating physician's and site's local standard of care until local disease progression is identified. After discontinuation, subsequent care and follow-up are per treating physician's and site's local standard. There is no protocol defined post-treatment assessments mandated.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 years
- •Histologically or cytologically confirmed de novo pancreatic adenocarcinoma
- •Locally advanced, non-metastatic disease
- •ECOG performance status of 0-2
- •Candidate for treatment with gemcitabine and nab-paclitaxel
- •Able to operate the NovoTTF-200T system independently or with caregiver support
排除标准
- •Prior palliative treatment to the pancreatic tumor
- •Other active malignancies within the past 5 years (except certain early-stage cancers)
- •Significant uncontrolled medical conditions or infections that would interfere with therapy
- •Implantable electronic devices in the torso
- •Known severe hypersensitivity to adhesives, hydrogel, or chemotherapy agents
- •Pregnancy or breastfeeding