Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

INCLUSION CRITERIA:

General inclusion criteria:

  • Patients ≥ 18 years old
  • more than 6 months of life expectancy as assessed by the investigator
  • Performance status ECOG 0 ; 1 or 2
  • Patient affiliated to or beneficiary of French social security system
  • Informed consent of the subject to participate in the study

Specific eligibility criteria:

  • Cohort A [Patients with advanced digestive or gynecological cancers eligible to immunotherapies]: Patients with locally advanced or metastatic digestive or gynecological cancers A1: hepatocellular carcinoma eligible to immunotherapy ± antiangiogenic A2: biliary tract carcinoma eligible to chemo-immunotherapy A3: oesogastric carcinoma eligible to chemo-immunotherapy A4: other digestive localizations eligible to immunotherapy (anti-PD1/PDL1 ± anti-CTLA4) ± chemotherapy A5: gynecological cancers eligible to chemo-immunotherapy
  • Cohort B [Patients with advanced digestive or gynecological cancers eligible to chemotherapy or targeted therapy without immunotherapy]: Patients with locally advanced or metastatic digestive or gynecological cancers B1: hepatocellular carcinoma eligible to antiangiogenic or chemotherapy B2: biliary tract carcinoma eligible to chemotherapy B3: oesogastric carcinoma eligible to chemotherapy B4: other digestive localizations eligible to chemotherapy and/or targeted therapy B5: gynecological cancers eligible to chemotherapy and/or targeted therapy
  • Cohort C [Patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy]: Patients with liver metastasis of colorectal cancer or peritoneal metastasis of ovarian cancer eligible to surgical resection

EXCLUSION CRITERIA :

General exclusion criteria:

  • Patient under guardianship, curatorship or under the protection of justice
  • Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  • Patient unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
  • Patient without health insurance
  • Pregnant women
  • Subject within the exclusion period of another study or planned by the national volunteer file

Study details
    Advanced Digestive Cancer
    Advanced Gynecologic Cancer

NCT06626269

Centre Hospitalier Universitaire de Besancon

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.