Clinical trial NCT01556282: TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Portal Vein Thrombosis
Keywords: Hepatocellular Carcinoma
portal vein thrombosis
HCC
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

Detailed description: Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.

Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

Eligibility criteria: 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.

Primary outcomes:
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:
measure: Progression free survival for patients with unresectable liver cancer.
timeFrame: Participants will be followed through 1 year after receiving treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Hyun s Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xing 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.
citation: Kokabi 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.