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NCT07436988

PHASE1

Affordable Made-in-India Microspheres for Liver Cancer Therapy

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-15

Completion Date

2028-10-15

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Hepatecellular Carcinoma

Interventions

DEVICE

90Y-Theraspheres

Standard-of-care 90Y-Theraspheres will be delivered via femoral artery catheter under digital subtraction angiography (DSA) for intra-arterial SIRT. Pre-therapy angiographic mapping and 99mTc-MAA lung shunt study will be conducted at least one week before SIRT to delineate hepatic arterial anatomy, detect extrahepatic shunts, and determine lung shunt fraction for personalized dose calculation. On the day of therapy, the patient will undergo a second femoral artery catheterization, and the calculated 90Y-Theraspheres dose will be infused selectively into the hepatic artery supplying the tumor. Intra-procedural DSA imaging will monitor catheter position, stasis, and microsphere delivery. Post-therapy PET-CT will be performed to assess microsphere distribution. The absorbed doses to tumor, healthy liver and lungs will be estimated using partition method. Patients will be monitored for laboratory parameters, adverse events, and tumor response using mRECIST criteria up to 12 weeks.

DEVICE

188Re-Microspheres

Indigenous 188Re-Microspheres will be administered via femoral artery catheter under DSA for intra-arterial SIRT. Pre-therapy angiographic mapping and lung shunt assessment using 99mTc-Microspheres will be performed on the same day to delineate hepatic arterial anatomy, detect extrahepatic shunts, and determine lung shunt fraction for administered activity estimation. The 188Re-Microspheres will be selectively infused into the hepatic artery supplying the tumor, with intra-procedural DSA monitoring for catheter placement and stasis. Post-therapy SPECT/CT will be performed 24-48 hours after administration, allowing accurate confirmation of microsphere distribution and dosimetry, which is an advantage over standard 90Y-Theraspheres requiring separate pre- and post-procedure imaging. This single-session approach reduces procedural complexity and resource use. Patients will be monitored for laboratory parameters, adverse events, and tumor response using mRECIST criteria up to 12 weeks.

Inclusion Criteria: 1. Age greater than or equal to 18 years (male or female) 2. Histologically or radiologically confirmed diagnosis of HCC deemed inoperable 3. Barcelona Clinic Liver Cancer stage B with ECOG performance status between 0 and 2 4. At least one measurable lesion with longest diameter greater than or equal to 5 cm on cross sectional imaging 5. Portal vein thrombosis may be present or absent 6. Laboratory criteria: 1. Serum creatinine less than or equal to 1.5 mg per dL 2. Total bilirubin less than or equal to 2.0 mg per dL 3. AST or ALT less than or equal to 5 times upper limit of normal 4. Leukocyte count greater than or equal to 1500 per microliter 5. Platelet count greater than or equal to 50000 per microliter 6. Prothrombin time less than or equal to 1.3 times control or INR less than or equal to 1.5 7. Karnofsky performance status greater than 70 8. Ability and willingness to provide written informed consent for participation in the IEC approved protocol Exclusion Criteria: 1. Women of childbearing potential who are unwilling or unable to use effective contraception or who are pregnant or lactating 2. Child Pugh class C liver function 3. Presence of extrahepatic metastases 4. Severe chronic pulmonary disease with hypoxemia or NYHA class three or four heart failure 5. Myocardial infarction within the past six months 6. Unstable arrhythmia or symptomatic cardiac disease 7. Any other serious uncontrolled illness that in the investigator's opinion would compromise study participation 8. History of other malignancy except adequately treated basal cell carcinoma or cervical carcinoma in situ within the last five years 9. Major surgery within four weeks prior to enrolment 10. Active uncontrolled bacterial infection requiring systemic therapy 11. Liver rupture, tumor penetration of the liver capsule, tumor invasion of the biliary system, or biliary obstruction 12. Known allergy or hypersensitivity to any component of the investigational or comparator microspheres 13. Prior treatment with Selective Internal Radiation Therapy (SIRT) 14. Estimated overall survival less than one month

Locations (5)

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