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

NCT07575854 | Not Yet Recruiting DMC

• 1 other identifier: 2025-A01223-46
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Gastrointestinal Cancer

Keywords

splenomegaly; chemotherapy-induced thromobocytopenia; Splenic Selective Internal Radiation Therapy; TheraSphere

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Based on Dose Limiting Toxicity (DLT) within 28 days

  28 days post-treatment

Study Arms (3)

Splenic SIRT with TheraSphere 100 Gy

EXPERIMENTAL

Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 100 Gy.

Device: TheraSphere

Splenic SIRT with TheraSphere 150 Gy

EXPERIMENTAL

Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 150 Gy.

Device: TheraSphere

Splenic SIRT with TheraSphere 200 Gy

EXPERIMENTAL

Patients receive a single administration of Yttrium-90 TheraSphere via Splenic artery with dose 200 Gy.

Device: TheraSphere

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.

Splenic SIRT with TheraSphere 100 Gy; Splenic SIRT with TheraSphere 150 Gy; Splenic SIRT with TheraSphere 200 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG 0-2
• 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)
• 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)
• Women patient of childbearing potential or male patient must agree to have efficient birth control method from ICF signature to 3 months after SIRT procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (4)

Centre Georges-François Leclerc

Dijon, 21000, France

Location

CHU Saint Eloi

Montpellier, 34295, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Splenomegaly

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François FG GODARD, Doctor

CONTACT

03 80 73 36 95; fgodard@cgfl.fr

Emilie ER REDERSTORFF, Project Manager

CONTACT

03 45 34 81 16; erederstorff@cgfl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)