Advanced Digestive CancerHORIZONNCT06626269
Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies
A study testing Blood sample and Tumor tissue in people with Advanced Digestive Cancer and Advanced Gynecologic Cancer, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Digestive Cancer, Advanced Gynecologic Cancer
- What is being tested?
- Blood sample and Tumor tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Feb 2025to Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital of Besançon
Besançon, 25000
Christophe BORG, Pr
- Not yet recruiting
Georges François Leclerc center
Dijon, 21000
François GHIRINGHELLI, Pr
About this study
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.
Read more
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.
- Being tested
- Blood sample, Tumor tissue
- Keywords
- biomarker, immunology, gynecologic cancer, digestive cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic 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 tissueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| blood test | Experimental | 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. Receives: Diagnostic Test: Blood sample; Other: Tumor tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation
Progression free survival (PFS) at 6 months post treatment initiation, defined as:
- non progressive alive patients: if patients are alive without progression in the 6 months from the date of treatment initiation
- or progressive or death patients: if patients are identified with a progression or a death in the 6 months from the date of treatment initiation
- patients without progression or death and with follow up bellow than 6 months are not assessable for PFS status at 6 months Progression-free survival (PFS): defined as the delay from the date of treatment initiation to the disease progression or death from any cause whichever occurs first. Alive patient without progression will be censored at last radiological evaluation available showing no progression.
Measured: 6 months post treatment initiation
For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases
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.
Measured: 6 months after surgery of metastases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start10 Feb 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Digestive CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626269
- Sponsor's protocol ID
- 2023/841
- Acronym
- HORIZON
- Status last verified
- Jun 2025
- First submitted
- 2 Oct 2024
- Last updated
- 20 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies
- ClinicalTrials.gov ID
- NCT06626269
- Acronym / sponsor ID
- HORIZON / 2023/841
- Keywords
- biomarker, immunology, gynecologic cancer, digestive cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood test | Experimental | Diagnostic Test: Blood sample, Other: Tumor tissueIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleIn 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) | Diagnostic test | blood test |
| Tumor tissueCohort 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. | Other | blood test |
Primary outcome
for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation
Time frame: 6 months post treatment initiation
Progression free survival (PFS) at 6 months post treatment initiation, defined as: * non progressive alive patients: if patients are alive without progression in the 6 months from the date of treatment initiation * or progressive or death patients: if patients are identified with a progression or a death in the 6 months from the date of treatment initiation * patients without progression or death and with follow up bellow than 6 months are not assessable for PFS status at 6 months Progression-free survival (PFS): defined as the delay from the date of treatment initiation to the disease progression or death from any cause whichever occurs first. Alive patient without progression will be censored at last radiological evaluation available showing no progression.
For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases
Time frame: 6 months after surgery of metastases
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Tumor tissue in people with Advanced Digestive Cancer and Advanced Gynecologic Cancer, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe BORG, PU-PH (+33(0)381668166, xtoph.borg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation (time frame: 6 months post treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2025.