Not Yet RecruitingNot Applicable

A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer

France18 participantsStarted 2026-10-01

Plain-language 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 with splenomegaly

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count ≥ 1000/mm³
✓. Hemoglobin ≥ 8.0 g/dL
✓. Creatinine \< 1.5 × ULN or creatinine clearance ≥ 40mL/min (Cockcroft-Gault formula)
✓. ALT and AST ≤ 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)

What they're measuring

Maximum Tolerated Dose

Timeframe: 28 days post-treatment

Trial details

NCT IDNCT07575854

SponsorCentre Georges Francois Leclerc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

François FG GODARD, Doctor

03 80 73 36 95 fgodard@cgfl.fr

View on ClinicalTrials.gov More Gastrointestinal Cancer trials