Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06626269

Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies

Led by Centre Hospitalier Universitaire de Besancon · Updated on 2025-06-20

700

Participants Needed

2

Research Sites

363 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The immune system may be involved in the recognition and destruction of tumor cells or cells undergoing transformation. It is also currently accepted that the quality of immune responses can influence the evolution of cancers after chemotherapy. In this context, it is possible to assess the presence of specific T cells in patients\' blood and to correlate the presence of specific memory lymphocytes with the quality of long-term clinical protection. The analysis of immune responses can also be based on i) analysis of the tumor microenvironment (analysis of surgical samples or biopsies) or ii) analysis of molecules secreted in plasma. Today, the immunotherapies can generate clinical responses in several cancers (for 15 to 25% of patients with melanomas, bladder, lung, kidney or gastric cancers). But the development of these drugs raises two unresolved questions: i) what immunological parameters predict the efficacy of these treatments? ii) why do some cancers remain refractory to the efficacy of these immunomodulatory drugs? It is therefore necessary to identify biomarkers for prognostic stratification and monitoring of patients treated by immunotherapy. The primary objective of our research team is to identify biomarkers related to the immune system or tumor microenvironment in order to better define patient eligibility criteria for immunotherapy strategies.

CONDITIONS

Official Title

Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years old or older
  • Expected to live more than 6 months as judged by the investigator
  • Performance status ECOG 0, 1, or 2
  • Affiliated with or a beneficiary of the French social security system
  • Provided informed consent to participate
  • Cohort A: Patients with locally advanced or metastatic digestive or gynecological cancers eligible for immunotherapy or chemo-immunotherapy (specific cancer types detailed)
  • Cohort B: Patients with locally advanced or metastatic digestive or gynecological cancers eligible for chemotherapy or targeted therapy without immunotherapy
  • Cohort C: Patients with liver or peritoneal metastases eligible for surgery after chemotherapy
Not Eligible

You will not qualify if you...

  • Under legal guardianship, curatorship, or justice protection
  • Any medical or psychiatric condition making participation inappropriate
  • Unlikely to cooperate or poor cooperation expected
  • Without health insurance
  • Pregnant women
  • Currently within exclusion period of another study or listed on the national volunteer file

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital of Besançon

Besançon, France, 25000

Actively Recruiting

2

Georges François Leclerc center

Dijon, France, 21000

Not Yet Recruiting

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Research Team

C

Christophe BORG, PU-PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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