Clinical trial NCT06626269: Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies
Official title: Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Digestive Cancer
Advanced Gynecologic Cancer
Keywords: biomarker
immunology
gynecologic cancer
digestive cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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\&#39; 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 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

Primary outcomes:
measure: for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation
timeFrame: 6 months post treatment initiation
measure: For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases
timeFrame: 6 months after surgery of metastases
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital of Besançon
city: Dijon
country: France
facility: Georges François Leclerc center
Study officials:
References: