Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies (HORIZON)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christophe BORG, PU-PH
- Phone Number: +33(0)381668166
- Email: xtoph.borg@gmail.com
Study Locations
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-
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Besancon, France, 25000
- Recruiting
- University Hospital of Besancon
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Principal Investigator:
- Christophe BORG, Pr
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Dijon, France, 21000
- Not yet recruiting
- Georges François Leclerc center
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Principal Investigator:
- François GHIRINGHELLI, Pr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation
Time Frame: 6 months post treatment initiation
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Progression free survival (PFS) at 6 months post treatment initiation, defined as:
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6 months post treatment initiation
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For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases
Time Frame: 6 months after surgery of metastases
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RFS: defined as the delay from the date of surgery of metastases to the disease relapse or death from any cause whichever occurs first.
Alive patient without relapse will be censored at last radiological evaluation available showing no relapse.
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6 months after surgery of metastases
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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