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Could zapping the spleen fix Chemo's side effect?

NCT ID NCT07575854

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a new use of targeted radiation (SIRT) to the spleen in 18 adults with gastrointestinal cancer who have low platelets and an enlarged spleen from chemotherapy. The goal is to see if the procedure is safe and can raise platelet counts, helping patients stay on their cancer treatment. The study will also find the highest safe radiation dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Yttrium-90 glass microspheres (TheraSphere) delivered via radiation procedure
What this could lead to
If it works, this could offer a new way to manage chemotherapy-induced low platelets, allowing patients to continue cancer treatment without delays.
What could go wrong
This is a very early, small pilot study with only 18 participants, so results may not apply broadly. The radiation procedure carries risks like bleeding, infection, or damage to nearby organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Life expectancy of greater than 6 months * Adequate organ function as defined by the following: 1. Absolute neutrophil count ≥ 1000/mm³ 2. Hemoglobin ≥ 8.0 g/dL 3. Creatinine \< 1.5 × ULN or creatinine clearance ≥ 40mL/min (Cockcroft-Gault formula) 4. ALAT and ASAT ≤ 5 × ULN 5. 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Saint Eloi

    Montpellier, 34295, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre Georges-François Leclerc

    Dijon, 21000, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

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