Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- response rate according to metabolic status
研究概览
简要总结
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue.
While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied.
The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs).
To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma.
The data collected will be :
- Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data),
- Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46)
Primary objective is to assess the response to ICI depending on metabolic status.
Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response.
The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥18 years
- •patients receiving immune checkpoint inhibitors, used alone or as a combination with chemotherapy or tyrosine kinase inhibitor or other immune checkpoint inhibitor, for advanced renal cell or lung carcinoma.
- •Patient Informed and signed the consent to participate in the research
排除标准
- •patients with history of auto immune disease
- •patients enrolled in an interventional study or be in the exclusion period following a previous research, if applicable
- •Patient not affiliated to the social security scheme or under AME
- •Patient under guardianship or curatorship or under legal protection
- •Patient unable or unwilling to give written consent
- •Pregnant patient
- •be in the exclusion period following a previous research, if applicable
结局指标
主要结局
response rate according to metabolic status
时间窗: 6 months from randomisation
response rate after 6 months of ICI treatment (iRECIST criteria)
次要结局
- 6 months progression free survival according to metabolic status(6 months from randomisation)
- 12 months overall survival according to metabolic status(12months from randomisation)
- correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI(12 months from randomisation)
- incidence of irAEs according to metabolic profile(6 months from randomisation)