Trial Outcomes & Findings for SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma (NCT NCT00503867)

NCT ID: NCT00503867

Last Updated: 2020-12-10

Results Overview

Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: From date of enrollment until the date of death from any cause assessed up 24 weeks.
• Results posted on: 2020-12-10

Participant Flow

Three medical centers in the US enrolled 10 patients from July 18, 2007 to March 9, 2010.

Participant milestones

Measure	SIR-Spheres Microspheres Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	SIR-Spheres Microspheres Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1

Baseline Characteristics

SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Hepatic Arterial Radioembolization SIR-Spheres Microspheres n=10 Participants SIR-Spheres microspheres SIR-Spheres microspheres: SIR-Spheres Yttrium-90 microspheres
Age, Continuous	68.0 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
ECOG performance status 0 (full activity)	8 Participants n=5 Participants
ECOG performance status 1 (ambulatory restricted)	2 Participants n=5 Participants
Previous chemotherapy Yes	1 Participants n=5 Participants
Previous chemotherapy No	9 Participants n=5 Participants
Previous radiotherapy Yes	1 Participants n=5 Participants
Previous radiotherapy No	9 Participants n=5 Participants
Disease characteristics Okuda Stage 1	10 Participants n=5 Participants
Disease characteristics CLIP score Class 1	4 Participants n=5 Participants
Disease characteristics CLIP score Class 2	2 Participants n=5 Participants
Disease characteristics CLIP score Class Unknown	4 Participants n=5 Participants
Disease characteristics Cirrhosis (Yes)	8 Participants n=5 Participants
Disease characteristics Cirrhosis (No)	2 Participants n=5 Participants
Disease characteristics TNM Classification of Primary Tumor, T2	2 Participants n=5 Participants
Disease characteristics TNM Classification of Primary Tumor, T3	6 Participants n=5 Participants
Disease characteristics TNM Classification of Primary Tumor, T4	2 Participants n=5 Participants
Disease characteristics TNM Classification of regional lymph nodes (No)	10 Participants n=5 Participants
Disease characteristics Hepatitis B (Yes)	1 Participants n=5 Participants
Disease characteristics Hepatitis B (No)	9 Participants n=5 Participants
Disease characteristics Hepatitis C (Yes)	3 Participants n=5 Participants
Disease characteristics Hepatitis C (No)	7 Participants n=5 Participants
Disease characteristics Metabolic Liver Disease (No)	10 Participants n=5 Participants
Disease characteristics History of alcohol abuse (Yes)	3 Participants n=5 Participants
Disease characteristics History of alcohol abuse (No)	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of enrollment until the date of death from any cause assessed up 24 weeks.

Population: Safety population - all patients who received initial SIRT treatment.

Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.

Outcome measures

Measure	SIR-Spheres Microspheres n=10 Participants Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
Number of Participants With Adverse Events Grade 3 or Higher	3 Participants

SECONDARY outcome

Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Population: This outcome measure was not assessed as no data was collected prior to termination of the study.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Population: This outcome measure was not assessed as no data was collected prior to termination of the study.

Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Population: This outcome measure was not assessed as no data was collected prior to termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Population: This outcome measure was not assessed as no data was collected prior to termination of the study.

Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.

Outcome measures

Outcome data not reported

Adverse Events

SIR-Spheres Microspheres

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	SIR-Spheres Microspheres n=10 participants at risk Radioembolization treatment with SIR-Spheres microspheres is administered within 28 days of enrollment into the study.
Hepatobiliary disorders Hyperbilirubinemia	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
Investigations International Normalised Radio Increased	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
General disorders Asthenia	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
Cardiac disorders Dyspnoea	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
General disorders Chest Pain	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.
Gastrointestinal disorders Abdominal Distention	10.0% 1/10 • Number of events 1 • From consent until 24 weeks post last dose of protocol chemotherapy.

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Sirtex Medical

Phone: 011 61 2 9964 8470

Email: dcade@sirtex.com

Results disclosure agreements

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