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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE BESANCON · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how the immune system responds to cancers, specifically advanced digestive and gynecologic cancers. Researchers are looking for specific markers in the blood and tumor samples that can help predict how well immunotherapy treatments will work for individual patients. Immunotherapy is a type of treatment that helps the immune system recognize and fight cancer cells. Currently, we know that these treatments can help some patients, but not everyone responds to them. By identifying certain biomarkers, the study aims to improve how doctors select patients for immunotherapy and monitor their responses.

To participate in this trial, you must be at least 18 years old, have a life expectancy of more than six months, and be eligible for certain cancer treatments based on your specific diagnosis. This includes patients with advanced digestive or gynecological cancers. Participants will undergo tests to analyze their blood and tumor samples, which may involve surgical procedures or biopsies. If you decide to join the study, you will be asked to provide informed consent, meaning you understand what the study involves and agree to participate. This research could lead to better treatment options for future patients facing similar cancer challenges.

Gender

ALL

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