Hepatocellular CarcinomaPhase 1ICARNCT00562666
Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells
A Phase 1 study testing T gamma delta lymphocytes in people with Hepatocellular Carcinoma, run by Rennes University Hospital at 3 sites in France.
Trial summary
For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- T gamma delta lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 1
- 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
- Adult over 18
- Hepatocellular carcinoma histologically proven, with at least one measurable tumor
- Non operable tumor
- Alfa foeto protein > 400 ng/ml
- Other treatments (surgery, chemoembolization) non indicated
- Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
Show all 25Show fewer
- Performance status WHO < 2
- Life expectancy > 3 months
- Non inclusion Criteria:
- Extra hepatic metastases
- Severe hepatopathy (Child B or C)
- Virus B or C chronic hepatitis
- Chronic cardiac failure
- Uncontrolled severe infectious disease
- Other cancer, if not considered as cured
- Positive serology for HIV or HTLV
- Leucocytes < 3000/mm3 or neutrophils < 1500/mm3
- Platelets < 80000/mm3
- Serum creatinine > 110 µmol/L
- Bilirubin > 35 µmol/L
- AST, ALT, alkaline phosphatase > 5N
- Current immunosuppressive treatment
- Impossibility to comply with scheduled follow-up
- Anatomical situation not permitting the selective injection of the product of cell therapy
- Pregnant or breastfeeding woman, or not using adequate effective contraceptive method
Who cannot join
- Insufficient number of gamma delta lymphocytes after expansion
Trial locations and contacts
3 sites in 1 country.
France3 sites
Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
Rennes, 35000
Département d'Oncologie Médicale - CRLCC Eugène Marquis
Rennes, 35042
Service de Chirugie Viscérale - Hôpital de Pontchaillou
Rennes
About this study
Official title: Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study
For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- T gamma delta lymphocytes
- Keywords
- cell therapy, T lymphocytes, hepatic intra-arterial injection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T gamma delta lymphocytesOther
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes Receives: Other: T gamma delta lymphocytes |
| 2 | Experimental | Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes Receives: Other: T gamma delta lymphocytes |
| 3 | Experimental | Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes Receives: Other: T gamma delta lymphocytes |
| 4 | Experimental | Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes Receives: Other: T gamma delta lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
Measured: Within 14 days after treatment
Secondary outcomes (1)
Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innate Pharma
- Responsible party
- Sponsor
- Investigators
- Jean-Luc RAOUL, MD, PhD, Principal investigator, CRLCC Eugène Marquis, RennesEric BELLISSANT, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562666
- Sponsor's protocol ID
- ID RCB 2007-A00249-44
- Other IDs
- CIC 0203/074, LOC 06/07
- Acronym
- ICAR
- Status last verified
- Jun 2012
- First submitted
- 21 Nov 2007
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study
- ClinicalTrials.gov ID
- NCT00562666
- Acronym / sponsor ID
- ICAR / ID RCB 2007-A00249-44
- Conditions
- Hepatocellular Carcinoma
- Keywords
- cell therapy, T lymphocytes, hepatic intra-arterial injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Innate Pharma
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Nov 2007 (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.
For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: T gamma delta lymphocytesSingle hepatic intra arterial administration of 500 millions T gamma delta lymphocytes |
| 2 | Experimental | Other: T gamma delta lymphocytesSingle hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes |
| 3 | Experimental | Other: T gamma delta lymphocytesSingle hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes |
| 4 | Experimental | Other: T gamma delta lymphocytesSingle hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Adult over 18
- Hepatocellular carcinoma histologically proven, with at least one measurable tumor
- Non operable tumor
- Alfa foeto protein > 400 ng/ml
- Other treatments (surgery, chemoembolization) non indicated
Key exclusion criteria (1 listed)
- Insufficient number of gamma delta lymphocytes after expansion
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 |
|---|---|---|
| T gamma delta lymphocytesSingle hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes | Other | 1, 2, 3, 4 |
Primary outcome
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
Time frame: Within 14 days after treatment
1 secondary outcome
Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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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.
Jean-Luc RAOUL, MD, PhD principal investigator
CRLCC Eugène Marquis, Rennes
Eric BELLISSANT, MD, PhD study chair
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T gamma delta lymphocytes in people with Hepatocellular Carcinoma, run by Rennes University Hospital at 3 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 25 inclusion and 1 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction (time frame: Within 14 days after treatment). 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 22 Jun 2012.