NL-OMON51244尚未招募不适用
The effects of an oncology tailored nutritional intervention on the bioavailability and immune-activity of PD-1 immune checkpoint inhibitors in patients with lung cancer: *Nutritional intervention in cancer immunotherapy (NutriCim) * - NutriCim
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
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
- •Participants are eligible to be included in the study if the following criteria
- •Age > 18 years
- •Patient must be willing and capable of giving written Informed Consent, and
- •meeting all study requirements
- •Capable of oral intake and digestion of the nutritional test product
- •Subjects with cytologically confirmed Stage IV or recurrent NSCLC, who have
- •not received prior systemic therapy treatment for their advanced NSCLC.
- •Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or
- •radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy
- •was completed at least 6 months prior to the diagnosis of metastatic disease.
排除标准
- •Subject with an active auto-immune disease requiring systemic treatment
- •Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or
- •equivalent dose of other steroid)
- •Previous allogeneic or organ transplant
- •Serious concomitant systemic disorders (for example active infection,
- •unstable cardiovascular disease) which in the opinion of the investigator would
- •compromise the patient's ability to complete the study, or would interfere with
- •the evaluation of the efficacy and safety of the study treatment
- •Known positive test for hepatitis B virus or hepatitis C virus or human
- •immunodeficiency virus (HIV) indicating acute or chronic infection
- •Allergy to cow*s milk protein, soy or fish, requiring a fibre-free diet or
- •suffering galactosemia or lactose intolerance
- •Moderate to severe hypercalcemia, i.e. total calcium level corrected for
- •albumin >=142.0 mg/dL (3.05 mmol/L )
- •Patient has had other malignancies within the past 3 years , except for
- •stable non-melanoma skin cancer, fully treated and stable early stage prostate
- •cancer or carcinoma in situ of the cervix or breast without need of treatment
- •Simultaneous participation in other clinical trial
- •Pregnant or lactating women
研究者
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