Gastrointestinal CancerSPLENIC-SIRTNCT07575854
A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer
A study testing TheraSphere in people with Gastrointestinal Cancer, run by Centre Georges Francois Leclerc at 4 sites in France.
Trial summary
This is a prospective, interventional, open-label, single-arm, multicenter pilot study evaluating the safety, tolerability and maximum tolerated dose (MTD) of splenic Selective Internal Radiation Therapy (SIRT) using TheraSphere in adult patietns with gastrointestinal cancer and chemotherapy-induced thrombocytopenia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- TheraSphere
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2026to 1 Apr 2029
- 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
- Written informed consent prior to performing any protocol-related procedures, including screening evaluations.
- Adult aged 18 years or above.
- Metastatic or non-metastatic gastrointestinal cancer (gastric, pancreatic, colorectal…) histologically proven.
- Splenomegaly validated by Splenic volume greater than or equal to 275 mL on imaging associated with thrombocytopenia (3D volumetry)
- Ongoing thrombocytopenia with serum platelet count ≤ 80.000 mm³ observed on 2 consecutive biological assessments performed at least 7 days apart and at the latest 1 month apart. The second biological assessments should be dated at the latest 3 days from enrolment.
- Eastern Cooperative Oncology Group (ECOG) 0-2
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- Life expectancy of greater than 6 months
- Adequate organ function as defined by the following:
- Absolute neutrophil count ≥ 1000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Creatinine < 1.5 × ULN or creatinine clearance ≥ 40mL/min (Cockcroft-Gault formula)
- ALAT and ASAT ≤ 5 × ULN
- Prothrombin Rate (PR) > 50 % (non-correctable*) and Activated Partial Thromboplastin time (APTT) < 1,5 second (non-correctable *) * non-correctable coagulopathy is defined as persistent coagulation abnormalities that cannot be corrected, even with appropriate therapeutic interventions (e.g., coagulation factor concentrates, vitamin K, or other corrective treatments)
- Women patient of childbearing potential or male patient must agree to have efficient birth control method from inform consent form signature to 3 months after Selective internal radiation therapy (SIRT) procedure.
Who cannot join
- Serum platelet count ≤35 000/ mm³.
- History of prior partial splenic embolization, splenectomy or any significant medical history affecting the spleen including medical history of proven cirrhosis with at least one episode of decompensation in the last 6 months from enrolment.
- Any non-Chemotherapy-Induced Thrombocytopenia and/or Chemotherapy-Induced Thrombocytopenia without splenomegaly (as per example, but not limited to, thrombocytopenia related to bone marrow toxicity)
- Use of any treatment known to increase platelet count 1 month prior to Baseline.
- History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
- Contraindications to angiography and selective visceral catheterization (bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents).
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- Spleen anatomy and/or splenic arterials anatomy and/or technical constraints identified during screening test which does not allow safe and/or ability to deliver the planned target dose/activity of TheraSphere
- Serum platelet count ≤35 000/ mm³.
- History of prior partial splenic embolization, splenectomy or any significant medical history affecting the spleen including medical history of proven cirrhosis with at least one episode of decompensation in the last 6 months from enrolment.
- Any non-Chemotherapy-Induced Thrombocytopenia and/or Chemotherapy-Induced Thrombocytopenia without splenomegaly (as per example, but not limited to, thrombocytopenia related to bone marrow toxicity)
- Use of any treatment known to increase platelet count 1 month prior to Baseline.
- History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
- Contraindications to angiography and selective visceral catheterization (bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents).
- Spleen anatomy and/or splenic arterials anatomy and/or technical constraints identified during screening test which does not allow safe and/or ability to deliver the planned target dose/activity of TheraSphere
- History of bleeding disorder attributed to another cause other than thrombocytopenia (e.g., thrombopathy, coagulation disorder, gastric bleeding related to portal hypertension etc..) within 2 months of enrolment and/or any active bleeding disorder.
- Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, uncontrolled congestive heart failure or respiratory disease and any toxicity from a prior treatment incompatible with the performance of the procedure. Comorbidities or Investigator judgement of poor overall health status which may make the patient a poor candidate for locoregional treatment.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from ICF signature to 3 months after SIRT.
- Person not affiliated or not beneficiary of a social security scheme and/or
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:
- Pregnant, parturient, breast-feeding women
- Minors (see also inclusion criterion 1)
- Persons receiving psychiatric treatment
- Persons admitted to a health or social establishment for purposes other than research
- Person of full age under curatorship
- Adult subject to a mandate for future protection, a family authorization, or a guardianship measure
- Any contraindications to perform standard spleen SIRT procedure (for example, but not limited to splenic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis; contraindications to vaccination, etc.)
- Patients with persistent coagulation abnormalities in the following scenarios:
- Severe hepatic disease, where the production of coagulation factors is significantly impaired and cannot be corrected by standard treatments.
- Coagulopathy induced by anticoagulants (e.g., direct oral anticoagulants or warfarin), where correction is not possible due to treatment instability or poor response to antidotes.
- Severe hemostatic dysfunction, where correction is not achieved despite appropriate intervention to restore coagulation balance.
- Patients with Tc-99m MAA splenic arterial perfusion scintigraphy shows:
- any extra splenic uptake that may not be corrected by angiographic techniques. Any visual extra-splenic uptake that cannot be corrected by angiographic techniques.
- lung shunt that could result in the delivery of a dose greater than 30 Gy to the lungs
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Georges-François Leclerc
Dijon, 21000
François FG GODARD, Doctor, 03 80 73 36 95 ext. +33, fgodard@cgfl.fr
CHU Saint Eloi
Montpellier, 34295
Boris BG GUIU, Professor, 04 67 33 75 46 ext. +33, b-guiu@chu-montpellier.fr
Centre Eugène Marquis
Rennes, 35042
Julien JE EDELINE, Professor, 02 99 25 31 96 ext. +33, j.edeline@rennes.unicancer.fr
Institut Gustave Roussy
Villejuif, 94800
Paul PB BEUNON, Doctor, 01 42 11 23 04 ext. +33, Paul.beunon@gustaveroussy.fr
About this study
Official title: A Pilot Feasibility Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer
This is a prospective, interventional, open-label, single-arm, multicenter pilot study evaluating the safety, tolerability and maximum tolerated dose (MTD) of splenic Selective Internal Radiation Therapy (SIRT) using TheraSphere in adult patietns with gastrointestinal cancer and chemotherapy-induced thrombocytopenia with splenomegaly
- Conditions
- Gastrointestinal Cancer
- Being tested
- TheraSphere
- Keywords
- splenomegaly, chemotherapy-induced thromobocytopenia, Splenic Selective Internal Radiation Therapy, TheraSphere
- Medical subject headings
- Gastrointestinal Neoplasms, Splenomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphereDevice
Patients will receive a single administration of Yttrium-90 glass microspheres (TheraSphere) delivered via selective catheterization of the splenic artery as part of a Selective Internal Radiation Therapy (SIRT) procedure.
The treatment is performed by interventional radiology using a femoral or brachial arterial approach, followed by intra-arterial infusion of the microsphere through a microcatheter positioned in the splenic arterial branches.
A dose-escalation scheme is applied with three planned absorbed dose levels (100Gy, 150 Gy and 200 Gy) to determine the maximum tolerated dose (MTD). The administrated activity is calculated based on splenic volume and vascular anatomy assessed during pre-treatment imaging.
TheraSphere is administered once on Day 1, with no repeat dosing. Patients undergo post-procedural imaging and are followed for safety, efficacy and dosimetry outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 100 Gy | Experimental | Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 100 Gy. Receives: Device: TheraSphere |
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 150 Gy | Experimental | Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 150 Gy. Receives: Device: TheraSphere |
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 200 Gy | Experimental | Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 200 Gy. Receives: Device: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Based on Dose Limiting Toxicity (DLT) within 28 days
Measured: 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575854
- Sponsor's protocol ID
- 2025-A01223-46
- Acronym
- SPLENIC-SIRT
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT07575854
- Acronym / sponsor ID
- SPLENIC-SIRT / 2025-A01223-46
- Conditions
- Gastrointestinal Cancer
- Keywords
- splenomegaly, chemotherapy-induced thromobocytopenia, Splenic Selective Internal Radiation Therapy, TheraSphere
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 8 May 2026 (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.
This is a prospective, interventional, open-label, single-arm, multicenter pilot study evaluating the safety, tolerability and maximum tolerated dose (MTD) of splenic Selective Internal Radiation Therapy (SIRT) using TheraSphere in adult patietns with gastrointestinal cancer and chemotherapy-induced thrombocytopenia with splenomegaly
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 100 Gy | Experimental | Device: TheraSpherePatients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 100 Gy. |
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 150 Gy | Experimental | Device: TheraSpherePatients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 150 Gy. |
| Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 200 Gy | Experimental | Device: TheraSpherePatients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 200 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent prior to performing any protocol-related procedures, including screening evaluations.
- Adult aged 18 years or above.
- Metastatic or non-metastatic gastrointestinal cancer (gastric, pancreatic, colorectal…) histologically proven.
- Splenomegaly validated by Splenic volume greater than or equal to 275 mL on imaging associated with thrombocytopenia (3D volumetry)
- Ongoing thrombocytopenia with serum platelet count ≤ 80.000 mm³ observed on 2 consecutive biological assessments performed at least 7 days apart and at the latest 1 month apart. The second biological assessments should be dated at the latest 3 days from enrolment.
Key exclusion criteria (33 listed)
- Serum platelet count ≤35 000/ mm³.
- History of prior partial splenic embolization, splenectomy or any significant medical history affecting the spleen including medical history of proven cirrhosis with at least one episode of decompensation in the last 6 months from enrolment.
- Any non-Chemotherapy-Induced Thrombocytopenia and/or Chemotherapy-Induced Thrombocytopenia without splenomegaly (as per example, but not limited to, thrombocytopenia related to bone marrow toxicity)
- Use of any treatment known to increase platelet count 1 month prior to Baseline.
- History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
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 |
|---|---|---|
| TheraSpherePatients will receive a single administration of Yttrium-90 glass microspheres (TheraSphere) delivered via selective catheterization of the splenic artery as part of a Selective Internal Radiation Therapy (SIRT) procedure. The treatment is performed by interventional radiology using a femoral or brachial arterial approach, followed by intra-arterial infusion of the microsphere through a microcatheter positioned in the splenic arterial branches. A dose-escalation scheme is applied with three planned absorbed dose levels (100Gy, 150 Gy and 200 Gy) to determine the maximum tolerated dose (MTD). The administrated activity is calculated based on splenic volume and vascular anatomy assessed during pre-treatment imaging. TheraSphere is administered once on Day 1, with no repeat dosing. Patients undergo post-procedural imaging and are followed for safety, efficacy and dosimetry outcomes. | Device | Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 100 Gy, Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 150 Gy, Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 200 Gy |
Primary outcome
Maximum Tolerated Dose
Time frame: 28 days post-treatment
Based on Dose Limiting Toxicity (DLT) within 28 days
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 13 May 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere in people with Gastrointestinal Cancer, run by Centre Georges Francois Leclerc at 4 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 14 inclusion and 33 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 François FG GODARD, Doctor (03 80 73 36 95 ext. +33, fgodard@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 28 days post-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 13 May 2026.