Affordable Made-in-India Microspheres for Liver Cancer Therapy

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

Primary liver tumors, with hepatocellular carcinoma (HCC) accounting for 80%, represent 6% of global cancer incidence and 9% of global cancer-associated mortality.HCC remains the leading causes of cancer-related deaths worldwide, due to late diagnosis. Although local-stage liver tumors are curable with tumor resection or livertransplantation, 65-70% of diagnosed cases are not suitable for resection due to large or multifocal lesions. For these patients, local therapies such as transcatheterarterial chemoembolization (TACE) or selective internal radiation therapy (SIRT) are appropriate at intermediate stages. In cases of advanced and metastatic livertumors, systemic therapies like sorafenib are the standard approach. Selective Intra-arterial Radionuclide Therapy (SIRT) offers a promising treatment for inoperableliver tumors by delivering beta-emitting radiolabeled microspheres directly to tumor sites through the liver's dual blood supply. However, the high cost of standard90Y-microspheres has limited accessibility for patients. This current project aims to develop, optimize, and validate the indigenously prepared microspheres forradiolabeling with 188Re from commercially available generator and indigenously produced radionuclide 177Lu (BARC Mumbai) for SIRT in liver cancer. With hightransformational impact, the current multicentric research will lead to a potentially safe, effective, and promising low-cost SIRT solution for low-income settings.Through collaboration across multiple centers, the study will evaluate the efficacy of microspheres labelled with both radionuclides. By establishing these accessibleSIRT options, this project strives to reduce financial barriers to treatment, advancing the goals of "Jai Anusandhan" towards building innovative therapeutics throughcollaborative research project and improving outcomes for patients with limited options.

Eligibility criteria

Qualifiers

Age greater than or equal to 18 years (male or female)

Histologically or radiologically confirmed diagnosis of HCC deemed inoperable

Barcelona Clinic Liver Cancer stage B with ECOG performance status between 0 and 2

At least one measurable lesion with longest diameter greater than or equal to 5 cm on cross sectional imaging

Disqualifiers

Women of childbearing potential who are unwilling or unable to use effective contraception or who are pregnant or lactating

Child Pugh class C liver function

Presence of extrahepatic metastases

Severe chronic pulmonary disease with hypoxemia or NYHA class three or four heart failure

Trial design

Treatments tested in this trial

  • 90Y-Theraspheres
  • 188Re-Microspheres

Treatment groups

18 Participants
are divided into 2 treatment groups

Sponsors and collaborators