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

Sponsor
Centre Georges Francois Leclerc
Study ID
NCT07575854
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TheraSphere — DEVICE
    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 Details

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

Key Dates

First listed
May 8, 2026
Start date
Oct 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Apr 1, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 100 Gy
    Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 100 Gy.
  • Experimental: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 150 Gy
    Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 150 Gy.
  • Experimental: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 200 Gy
    Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 200 Gy.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 28 days post-treatment ]

Central Contacts

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