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

NCT ID: NCT06626269

Last Updated: 2025-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2032-02-29

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' 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

Advanced Digestive Cancer; Advanced Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: DIAGNOSTIC_TEST

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)

Tumor tissue

Intervention Type: OTHER

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 for TIL and CAF + 1 tumor block in paraffin at time of surgery.

Interventions

Blood sample

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)

Intervention Type: DIAGNOSTIC_TEST

Tumor tissue

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 for TIL and CAF + 1 tumor block in paraffin at time of surgery.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Besançon

Besançon, , France

Site Status: RECRUITING

Georges François Leclerc center

Dijon, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Christophe BORG, PU-PH

Role: CONTACT

xtoph.borg@gmail.com

+33(0)381668166

Other Identifiers

2023/841

Identifier Type: -

Identifier Source: org_study_id