Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
研究概览
简要总结
The immune system plays a critical role in cancer progression and antitumor responses. Glioblastoma is an aggressive and incurable brain tumor characterized by a highly immunosuppressive microenvironment. Over the past two decades, photodynamic therapy (PDT) has been evaluated as an adjunct to fluorescent-guided resection (FGR) and chemoradiotherapy according to the STUPP protocol, for resectable glioblastomas. In addition to demonstrating the feasibility of such a procedure, two previous clinical trials (INDYGO, NCT03048240; DOSINDYGO, NCT04391062) revealed/highlighted significant systemic immune changes following treatment, including modifications in peripheral blood mononuclear cells (PBMCs) activation and cytokine secretion profiles. However, the specific contribution of PDT remains uncertain due to the combined effects of, on the one hand, PDT and, on the other hand, FGR and chemoradiotherapy. This study aims to evaluate immune parameters in a control population undergoing FGR and chemoradiotherapy only (i.e., without PDT). The objective is to distinguish the immunological impact of PDT from that of FGR and chemoradiotherapy. The results will provide a better understanding of the systemic immune modulation induced by PDT in glioblastoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient male or female ≥18 years
- •General status (WHO) of Performance status 0, 1 or 2
- •Probable glioblastoma according to clinical and radiological criteria,
- •whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
- •Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
- •Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
- •Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
- •Patient able to understand and sign voluntarily Informed consent
- •Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
- •Women of child-bearing potential should benefit of an effective contraception
- •For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
- •Patient assigned to an health insurance
排除标准
- •Contraindications to 5-ALA (Gliolan®)
- •Porphyria
- •Taking photosensitizer treatment
- •Severe renal or hepatic impairment
- •Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum rates
- •Creatinine clearance <30 mL / min;
- •Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
- •Contraindications to surgery
- •Contraindications to magnetic resonance imaging (MRI)
- •Treatment with an experimental drug within 30 Days prior to the start of the study
- •Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
- •Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
- •Pregnant or nursing women
- •Refusal to participate or sign the consent of the study
- •Soy allergy
研究组 & 干预措施
Control No PDT
17 patients with resectable glioblastoma undergoing FGR and chemoradiotherapy only (i.e., without PDT). These patients are matched 1:1 by age and sex with patients from the completed INDYGO (NCT03048240) and DOSINDYGO (NCT04391062) trials who underwent immunological analysis (6 INDYGO patients and 11 DOSINDYGO patients).
干预措施: Fluorescence-guided resection (FGR) (Procedure)
结局指标
主要结局
Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
时间窗: From baseline (pre-surgery) to 6 months post-surgery
Systemic immune response will be assessed by longitudinal changes in the proportion of circulating immune cell subsets quantified by flow cytometry and by cytokine concentrations measured through secretome analysis. All measurements will be analyzed as variations relative to a pre-operative baseline to evaluate immune modulation following resection and during chemoradiotherapy.
次要结局
- Evolution of immune cells transcriptomic profile(From baseline (pre-surgery) to 6 months post-surgery)
- Immunomodulatory effects of circulating exosomes following glioblastoma resection and during chemoradiotherapy(From baseline (pre-surgery) to 6 months post-surgery)