NL-OMON52292已完成不适用
A Clinical Evaluation of the Aliya* System in Late-Stage Cancer (INCITE LS) - INCITE LS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is eligible if diagnosed and currently under physician care for one
- •of the following advanced stage or metastatic conditions:
- •o Stage IV non-small cell lung cancer
- •o Stage IV hepatocellular carcinoma
- •o Stage IV renal cell carcinoma
- •Patient is currently receiving PD-1/PD-L1 axis immunotherapy as their most
- •recent line of therapy, either alone or in combination with standard of care
- •systemic therapy for their malignancy.
- •Patient has exhibited at least 6 months of response to PD-1/PD-L1 axis
- •immunotherapy regimen (defined as complete response (CR), partial response
- •(PR), or stable disease (SD) in their index tumors per RECIST 1.1) prior to
- •progression.
- •Patient has radiologically documented or confirmed progressive disease (per
- •RECIST 1.1) defined as a total of <= 5 new areas of growth on existing tumors
- •and/or new tumors.
- •New tumors must be <= 2cm in longest diameter. New areas of growth on existing
- •tumors must be <= 2cm in longest diameter. Tumors and new areas of growth must
- •be deemed suitable by the investigator for complete treatment with PEF.
- •Pathologic lymph nodes must be >= 15mm in short axis.
- •In the judgement of the investigator, the patient is able to remain on
- •PD-1/PD-L1 axis immunotherapy for at least 3 months after PEF treatment.
- •New tumors and areas of growth on existing tumors are amenable to standard of
- •care biopsy in order to confirm disease progression.
- •Patient must be willing to undergo biopsy of at least one tumor prior to PEF
- •treatment delivery unless there is documented histological confirmation of
- •malignancy within 4 weeks prior to PEF treatment.
- •Patient refuses surgery and/or stereotactic body radiotherapy (SBRT).
- •Life expectancy >= 12 weeks.
- •ECOG performance status 0-1.
排除标准
- •Patient has implanted lung devices or electronic devices.
- •Patient is receiving bevacizumab concurrently with their PD-1/PD-L1 axis
- •immunotherapy.
- •Patient has received any prior systemic therapy (systemic chemotherapy,
- •immunotherapy or investigational drug) in another study within 21 days prior to
- •study enrollment.
- •Patient is scheduled to receive any concurrent chemotherapy, immunotherapy,
- •biologic or hormonal therapy for off-label cancer treatment while on this
- •Patient has unresolved adverse reaction to immunotherapy that requires dose
- •modification.
- •Patient has received any radiation therapy within 6 weeks prior to study
- •enrollment.
- •Patient for whom the investigator considers that the PEF treatment is not in
- •the patient's best interest.
研究者
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