Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers.

NCT07568782 | Not Yet Recruiting

• 1 other identifier: 2024_0446
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy

  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.

  From baseline (pre-surgery) to 6 months post-surgery

Secondary Outcomes (2)

• 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

Study Arms (1)

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).

Procedure: Fluorescence-guided resection (FGR)

Interventions

Fluorescence-guided resection (FGR) PROCEDURE

Patients undergo fluorescence-guided resection for glioblastoma. Post-operative management includes standard radiochemotherapy according to the STUPP protocol. Peripheral blood samples are collected longitudinally for immunological analyses (PBMCs, immune activation markers, cytokine profiling). This group serves as a matched control cohort for patients in the INDYGO and DOSINDYGO trials who received PDT in addition to FGR and chemoradiotherapy.

Control No PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed resectable glioblastoma undergoing fluorescence-guided resection and chemoradiotherapy according to the STUPP protocol. The study includes a prospective control cohort treated with fluorescence-guided resection and chemoradiotherapy only (i.e., without photodynamic therapy (PDT)) and a historical prospective cohort previously treated with intraoperative PDT (INDYGO and DOSINDYGO trials) combined with fluorescence-guided resection and chemoradiotherapy. All patients receive standard post-operative Stupp protocol. Peripheral blood samples are analyzed for systemic immune profiling.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Lille University: collaborator

Study Sites (1)

CHU Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Peripheral Blood Mononuclear Cells, Serum

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nicolas REYNS, PU-PH

  CHU Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Pr REYNS, PU-PH

CONTACT

33 320 44 65 42; nicolas.reyns@chu-lille.fr

Nadira Pr DELHEM, PU

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)