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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital of Besançon
RECRUITING
Besançon
Georges François Leclerc center
NOT_YET_RECRUITING
Dijon
Contact Information
Primary
Christophe BORG, PU-PH
xtoph.borg@gmail.com
+33(0)381668166
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2032-02
Participants
Target number of participants: 700
Treatments
Experimental: blood test
In cohort A: patients with advanced digestive or gynecological cancers eligible to immunotherapies.~In cohort B: patients with advanced digestive or gynecological cancers eligible to treatment without immunotherapy.~In cohort C: patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon

This content was sourced from clinicaltrials.gov