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

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

NCT ID: NCT06626269

Condition: Advanced Digestive Cancer
Advanced Gynecologic Cancer

Conditions: Official terms:
Gastrointestinal Neoplasms

Conditions: Keywords:
biomarker
immunology
gynecologic cancer
digestive cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Blood sample
Description: In cohort A: 3 or 4 blood samples (for plasma and PBMC collection) : at baseline (before immunotherapy initiation); at 3 months ; at 12 months; on case of severe or unexpected toxicity. In cohort B: 3 blood sampes (for plasma and PBMC collection): at baseline (before treatment initiation); at 3 months ; at 12 months In cohort C: 2 blood samples (for plasma and PBMC collection) : at baseline (at the time of surgery); at 3 months (after surgery)
Arm group label: blood test

Intervention type: Other
Intervention name: Tumor tissue
Description: Cohort A and B: 1 tumor block in paraffin at diagnosis + 1 tumor block in paraffin at progression (optional) Cohort C: Fresh tumoral tissue fragments to be recovered in the operating room and sent to the ITAC platform for TIL and CAF + 1 tumor block in paraffin at time of surgery.
Arm group label: blood test

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital of Besançon

Address:
City: Besancon
Zip: 25000
Country: France

Contact:
Last name: Christophe BORG, Pr

Facility:
Name: Georges François Leclerc center

Address:
City: Dijon
Zip: 21000
Country: France

Contact:
Last name: François GHIRINGHELLI, Pr

Start date: October 2024

Completion date: October 2032

Lead sponsor:
Agency: Centre Hospitalier Universitaire de Besancon
Agency class: Other

Source: Centre Hospitalier Universitaire de Besancon

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06626269