Trial Outcomes & Findings for Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma (NCT NCT01290523)

NCT ID: NCT01290523

Last Updated: 2019-05-13

Results Overview

Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-05-13

Participant Flow

Yttrium-90 radioembolization there were 14 total patients who signed consent and participated in the study. Enrollment started in May2010 and ended in June 2013.

A 2nd radioembolization treatment was allowed if patients had bilobar tumors and were willing to get repeated treatments.

Participant milestones

Measure	Yttrium-90 Liver Radioembolization 1 Treatment Patients who received 1 liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Yttrium-90 Liver Radioembolization 1 Treatment Patients who received 1 liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Overall Study Death	3

Baseline Characteristics

Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Yttrium-90 Liver Radioembolization n=14 Participants Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain

Outcome measures

Measure	Yttrium-90 Liver Radioembolization n=14 Participants Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Number of Participants With Adverse Events	3 participants

SECONDARY outcome

Timeframe: 6 months

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT:

up to 5 lesions at baseline and sum longest diameters (SLD).

• Complete Response (CR), -Target Lesions: Disappearance of all target lesions.

-Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level.

• Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
• Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions.
• Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir

non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy

Outcome measures

Measure	Yttrium-90 Liver Radioembolization n=14 Participants Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Complete Response (CR)	0 Participants
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Partial Response (CR)	5 Participants
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Stable Disease (SD)	8 Participants
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Progressive Disease (PD)	1 Participants

Adverse Events

Yttrium-90 Liver Radioembolization

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Yttrium-90 Liver Radioembolization n=14 participants at risk Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Injury, poisoning and procedural complications Fatigue	21.4% 3/14 • Number of events 3

Additional Information

Dr Nicholas Fidelman

University of California San Francisco Department of Radiology

Phone: (415) 353-1300

Email: Nicholas.Fidelman@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place