Clinical trial · Interventional
TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
NCT01556282CI-TRIAL-00014713completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Portal Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therasphere
- interventionNames
- Device: TheraSphere
Primary outcomes (1)
- measure
- Response rate to the administration of Therasphere
- timeFrame
- Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits
Secondary outcomes (1)
- measure
- Progression free survival for patients with unresectable liver cancer.
- timeFrame
- Participants will be followed through 1 year after receiving treatment
- description
- Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 yrs of age or older * Diagnosis of Hepatocellular Carcinoma * Portal Vein Thrombosis * ECOG performance \< 2 -\>4 weeks since prior radiation, surgery or chemotherapy. * Life expectancy \> 3 months * Able to provide written informed consent process in accordance with institutional review boards guidelines. Exclusion Criteria: * Contraindications to angiography and selective visceral catheterization. * Evidence of blood flow to the lung from the liver greater than 16.5 mCi * Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow. * Significant extrahepatic disease. * Severe liver disfunction of pulmonary insufficiency. * Active uncontrolled infection. * Significant underlying medical or psychiatric illness. * Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
References
Publications (2)
- DERIVEDXing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1. PMID 29329568
- DERIVEDKokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6. PMID 25847227