NCT07436988Not yet recruitingPhase 1

Affordable Made-in-India Microspheres for Liver Cancer Therapy

Multicentric Study on Indigenous and Affordable Microspheres for Selective Internal Radiation Therapy (SIRT) of Unresectable Liver Cancer

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 18 (estimated)
First submitted: 19 Jan 2026
Start date: 15 Feb 2026
Primary completion date: 31 Jul 2028
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Diseases: Liver and biliary tract cancer
NCT number: NCT07436988

What you commit to

Study type: Interventional · Phase 1
Planned participants: 18
From 15 Feb 2026 to the primary completion date, 31 Jul 2028
5 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Major surgery within four weeks prior to enrolment
Prior treatment with Selective Internal Radiation Therapy (SIRT)

Other illness

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
Active uncontrolled bacterial infection requiring systemic therapy
Known allergy or hypersensitivity to any component of the investigational or comparator microspheres

Other

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
Liver rupture, tumor penetration of the liver capsule, tumor invasion of the biliary system, or biliary obstruction
Estimated overall survival less than one month

Who the study is looking for

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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
All India Institute of Medical Sciences Coordinator of this site? Confirm its status	Bhubaneswar	India	Unknown status
Postgraduate Institute of Medical Education and Research Coordinator of this site? Confirm its status	Chandigarh	India	Unknown status
All India Institute of Medical Sciences Coordinator of this site? Confirm its status	Delhi	India	Unknown status
Tata Memorial Hospital Coordinator of this site? Confirm its status	Mumbai	India	Unknown status
Jawaharlal Institute of postgraduate medical education and research Coordinator of this site? Confirm its status	Puducherry	India	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.