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

ConditionGastrointestinal Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Georges Francois Leclerc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

18 Participants

are divided into 3 treatment groups

Group A: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 100 GyExperimental treatment 1 intervention

Group B: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 150 GyExperimental treatment 1 intervention

Group C: Splenic Selective Internal Radiation Therapy (SIRT) with TheraSphere 200 GyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum Tolerated Dose

Based on Dose Limiting Toxicity (DLT) within 28 days

Time frame

28 days post-treatment

Sponsors and contacts

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Centre Georges Francois Leclerc

Lead sponsor

Source ClinicalTrials.gov

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