Affordable Made-in-India Microspheres for Liver Cancer Therapy

Starting soon · Phase 1

Conditions studied: Hepatecellular Carcinoma

In brief

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.

Key facts

Study ID: NCT07436988
Run by: Post Graduate Institute of Medical Education and Research, Chandigarh
People needed: 18
Starts: 2026-02-15
Expected to finish: 2028-10-15
Last updated by the study team: 2026-03-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Portal vein thrombosis may be present or absent
Laboratory criteria:
Serum creatinine less than or equal to 1.5 mg per dL
Total bilirubin less than or equal to 2.0 mg per dL
AST or ALT less than or equal to 5 times upper limit of normal
Leukocyte count greater than or equal to 1500 per microliter
Platelet count greater than or equal to 50000 per microliter
Prothrombin time less than or equal to 1.3 times control or INR less than or equal to 1.5
Karnofsky performance status greater than 70
Ability and willingness to provide written informed consent for participation in the IEC approved protocol

You may not qualify if…

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
Myocardial infarction within the past six months
Unstable arrhythmia or symptomatic cardiac disease
Any other serious uncontrolled illness that in the investigator's opinion would compromise study participation
History of other malignancy except adequately treated basal cell carcinoma or cervical carcinoma in situ within the last five years
Major surgery within four weeks prior to enrolment
Active uncontrolled bacterial infection requiring systemic therapy
Liver rupture, tumor penetration of the liver capsule, tumor invasion of the biliary system, or biliary obstruction
Known allergy or hypersensitivity to any component of the investigational or comparator microspheres
Prior treatment with Selective Internal Radiation Therapy (SIRT)
Estimated overall survival less than one month

Where it is running

Postgraduate Institute of Medical Education and Research — Chandigarh, Chandigarh, India
Tata Memorial Hospital — Mumbai, Maharashtra, India
All India Institute of Medical Sciences — Bhubaneswar, Odisha, India
Jawaharlal Institute of Postgraduate Medical Education and Research — Puducherry, Puducherry, India
All India Institute of Medical Sciences — Delhi, South Delhi, India

Full record on ClinicalTrials.gov

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