Immune and tumor microenvironment biomarkers to guide immunotherapy for advanced digestive and gynecologic cancers
Official title: Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies
Run by Centre Hospitalier Universitaire de Besancon · NCT06626269 · Data updated 2026-11-12
This project will test whether measuring immune cells and molecules in blood and tumor samples can help predict who with advanced digestive or gynecologic cancers will respond to immunotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Besançon and 1 other locations) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | February 2030 |
| Study ends | February 2032 |
| Registry record updated | June 20, 2025 |
| Trial ID | NCT06626269 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with locally advanced or metastatic digestive or gynecologic cancers who are eligible for immunotherapy or chemo‑immunotherapy, have ECOG 0–2, an investigator-estimated life expectancy >6 months, French social security coverage, and provide informed consent.
✕Probably not a fit
Patients without advanced digestive or gynecologic cancers, those not eligible for immunotherapy or chemotherapy as defined by the protocol, or those with poor performance status or very limited life expectancy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol collects blood samples and tumor tissue from adults with advanced digestive or gynecologic cancers to profile immune cells, memory lymphocytes, secreted plasma molecules, and features of the tumor microenvironment. Patients are enrolled in cohorts based on cancer type and planned treatment (immunotherapy or chemotherapy/targeted therapy), and samples are analyzed to identify biomarkers that correlate with treatment response or resistance. Analyses include characterization of T cell populations in blood, immunophenotyping of tumor-infiltrating lymphocytes from biopsies or surgical specimens, and measurement of circulating immune-related molecules. Sites include the University Hospital of Besançon and the Georges François Leclerc cancer center in Dijon, France, and findings will be compared with clinical outcomes to identify predictive markers.
Why it matters
Potential benefit: If successful, the trial could help clinicians predict which patients will benefit from immunotherapy and tailor treatments to improve outcomes.
How similar studies have gone: Previous studies have identified some predictive immune biomarkers (e.g., PD-L1, TILs, tumor mutational burden) with limited accuracy in various cancers, so this work builds on existing but incomplete evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital of Besançon
Besançon, France Recruiting -
Georges François Leclerc center
Dijon, France Not yet recruiting
Study contacts
- Study coordinator: Christophe BORG, PU-PH
- Email: xtoph.borg@gmail.com
- Phone: +33(0)381668166
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.