Carcinoma, HepatocellularNCT02439008
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
A study testing Blood samples collection before radiotherapy, Blood samples collection during radiotherapy and Blood samples collection after radiotherapy in people with Carcinoma, Hepatocellular and Colorectal Neoplasms, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma
- What is being tested?
- Blood samples collection before radiotherapy, Blood samples collection during radiotherapy and Blood samples collection after radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2015to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
- hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
- metastasis from melanoma or renal cancer,
- Age ≥ 18 years old,
- Registered with a social security system,
- Signed written informed consent.
Who cannot join
- Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
- Pregnant or breastfeeding woman,
- Patient under guardianship or tutorship.
Trial locations and contacts
1 site in 1 country.
About this study
This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.
Read the detailed description
- Patient information and collection of a signed informed consent form
- Clinical data collection
- Blood samples of 35 mL:
- after registration, prior to the first fraction of radiotherapy
- within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions
- one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session
- Storage of the blood samples at ambient temperature
- Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
- Destruction of the samples at the end of the analysis
- Being tested
- Blood samples collection before radiotherapy, Blood samples collection during radiotherapy, Blood samples collection after radiotherapy, Radiotherapy
- Keywords
- liver metastases of colorectal cancer, metastases of melanoma or renal cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collection before radiotherapyProcedure or surgery
Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment.
Before radiotherapy:
- Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy
Blood samples collection during radiotherapyProcedure or surgery
- Sample T1: within 15 minutes after the administration of the first fraction,
- Sample T2: within 15 minutes after the administration of the second fraction,
- Sample T3: within 15 minutes after the administration of the third fraction
Blood samples collection after radiotherapyProcedure or surgery
- Sample T4: one week after the end of the radiotherapy,
- Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy.
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Blood samples collection | Experimental | Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.
Interventions :
* Blood samples collection before radiotherapy (T0)
* Blood samples collection during radiotherapy (T1-T3)
* Blood samples collection after radiotherapy (T4-T8) Receives: Procedure: Blood samples collection before radiotherapy; Procedure: Blood samples collection during radiotherapy; Procedure: Blood samples collection after radiotherapy; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse of immunological parameters, decription of secreted markers and nanovesicles production
Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy
Measured: from baseline to 1 year follow up
Secondary outcomes (3)
Cell viability, determined by number of live/dead cells present
Cell viability and cell proliferation
Measured: from baseline to 1 year follow up
Progression-free rate
progression-free rate at 12 months
Measured: from baseline to 1 year follow up
Number of Participants with Adverse Events related to radiotherapy
adverse effects (acute toxicity) according to CTCAE-NCI
Measured: from baseline to 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start16 Sep 2015
- Primary completion21 Jun 2018
- Study completion18 Mar 2019
Why it stopped: Lack of patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Biologie de Lille
- Responsible party
- Sponsor
- Investigators
- Xavier Mirabel, MD, Study director, Centre Oscar LambretNadira Delhem, MD, Study director, Institut de Biologie de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439008
- Sponsor's protocol ID
- EarlyBio-HypoRT-WP3-1504
- Other IDs
- 2015-A00246-43
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2015
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
- ClinicalTrials.gov ID
- NCT02439008
- Acronym / sponsor ID
- EarlyBio-HypoRT-WP3-1504
- Keywords
- liver metastases of colorectal cancer, metastases of melanoma or renal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut de Biologie de Lille
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 8 May 2015 (estimated)
- 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.
This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.
Detailed description
- Patient information and collection of a signed informed consent form
- Clinical data collection
- Blood samples of 35 mL:
- after registration, prior to the first fraction of radiotherapy
- within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions
- one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session
- Storage of the blood samples at ambient temperature
- Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
- Destruction of the samples at the end of the analysis
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood samples collection | Experimental | Procedure: Blood samples collection before radiotherapy, Procedure: Blood samples collection during radiotherapy, Procedure: Blood samples collection after radiotherapy, Radiation: RadiotherapyNine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : * Blood samples collection before radiotherapy (T0) * Blood samples collection during radiotherapy (T1-T3) * Blood samples collection after radiotherapy (T4-T8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
- hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
- metastasis from melanoma or renal cancer,
- Age ≥ 18 years old,
- Registered with a social security system,
Key exclusion criteria (3 listed)
- Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
- Pregnant or breastfeeding woman,
- Patient under guardianship or tutorship.
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 samples collection before radiotherapyNine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment. Before radiotherapy: * Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy | Procedure or surgery | Blood samples collection |
| Blood samples collection during radiotherapy* Sample T1: within 15 minutes after the administration of the first fraction, * Sample T2: within 15 minutes after the administration of the second fraction, * Sample T3: within 15 minutes after the administration of the third fraction | Procedure or surgery | Blood samples collection |
| Blood samples collection after radiotherapy* Sample T4: one week after the end of the radiotherapy, * Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy. | Procedure or surgery | Blood samples collection |
| Radiotherapy | Radiation | Blood samples collection |
Primary outcome
Analyse of immunological parameters, decription of secreted markers and nanovesicles production
Time frame: from baseline to 1 year follow up
Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy
3 secondary outcomes
Cell viability, determined by number of live/dead cells present
Time frame: from baseline to 1 year follow up
Progression-free rate
Time frame: from baseline to 1 year follow up
Number of Participants with Adverse Events related to radiotherapy
Time frame: from baseline to 1 year follow up
Results and safety
The study was stopped early (reason given: Lack of patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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. This study is not recruiting at the moment.
Xavier Mirabel, MD study director
Centre Oscar Lambret
Nadira Delhem, MD study director
Institut de Biologie de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples collection before radiotherapy, Blood samples collection during radiotherapy and Blood samples collection after radiotherapy in people with Carcinoma, Hepatocellular and Colorectal Neoplasms, run by Centre Oscar Lambret at 1 site 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Lack of patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse of immunological parameters, decription of secreted markers and nanovesicles production (time frame: from baseline to 1 year follow up). 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 13 Mar 2026.