NCT07436988Toborzás még nem indult1. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 12.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 18 (tervezett)
- Első benyújtás
- 2026. jan. 19.
- Kezdés
- 2026. febr. 15.
- Elsődleges befejezés
- 2028. júl. 31.
- Fő szponzor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT07436988
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 18
- 2026. febr. 15. és az elsődleges befejezés (2028. júl. 31.) között
- 5 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Major surgery within four weeks prior to enrolment
- Prior treatment with Selective Internal Radiation Therapy (SIRT)
Más betegség
- 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
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| All India Institute of Medical Sciences | Bhubaneswar | India | Ismeretlen állapot |
| Postgraduate Institute of Medical Education and Research | Chandigarh | India | Ismeretlen állapot |
| All India Institute of Medical Sciences | Delhi | India | Ismeretlen állapot |
| Tata Memorial Hospital | Mumbai | India | Ismeretlen állapot |
| Jawaharlal Institute of postgraduate medical education and research | Puducherry | India | Ismeretlen állapot |
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