Trial Outcomes & Findings for HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC (NCT NCT00605150)
NCT ID: NCT00605150
Last Updated: 2022-04-22
Results Overview
Progression of liver cancer
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome timeframe
6 months
Results posted on
2022-04-22
Participant Flow
Total number of patients treated with TheraSphere was 11.
Candidates were selected by the physicians for treatment with TheraSphere, patient's signed informed consent and were treated if they met the criteria for treatment using the Humanitarian Device Exemption (HDE) protocol.
Participant milestones
| Measure |
Treatment
TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable hepatocellular carcinoma (HCC)
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
Baseline characteristics by cohort
| Measure |
TheraSphere Treatment
n=10 Participants
Total number of patients enrolled, TheraSphere treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 8.509 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of participants enrolled
Progression of liver cancer
Outcome measures
| Measure |
TheraSphere Treatment
n=11 Participants
Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
|
|---|---|
|
Progression
|
11 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
TheraSphere Treatment
n=11 Participants
Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
|
|---|---|
|
Number of Participants With Unacceptable Side Effects After Treatment
|
0 Participants
|
Adverse Events
TheraSphere Treatment for Patients With Unresectable HCC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place