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
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)
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.