Trial Outcomes & Findings for Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization (NCT NCT02762266)
NCT ID: NCT02762266
Last Updated: 2024-03-12
Results Overview
Local progression event: occurring in the treated hepatic lesion.
TERMINATED
PHASE3
13 participants
Up to 12 months
2024-03-12
Participant Flow
13 participants signed informed consent, 12 were randomized to a study arm.
Participant milestones
| Measure |
Transarterial Chemoembolization (TACE)
Patients undergo TACE using an embolic agent (gelatin sponge \[gelfoam\], polyvinyl alcohol particles, or embolic beads).
|
Stereotactic Body Radiation Therapy (SBRT)
Patients undergo image-guided SBRT (3 fractions within 1 week or 5 fractions within 2 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
Received Treatment
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Transarterial Chemoembolization (TACE)
Patients undergo TACE using an embolic agent (gelatin sponge \[gelfoam\], polyvinyl alcohol particles, or embolic beads).
|
Stereotactic Body Radiation Therapy (SBRT)
Patients undergo image-guided SBRT (3 fractions within 1 week or 5 fractions within 2 weeks).
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Participants with AFP data
Baseline characteristics by cohort
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 6.25 • n=4 Participants
|
67.7 years
STANDARD_DEVIATION 7.15 • n=6 Participants
|
68.6 years
STANDARD_DEVIATION 6.54 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
|
Region of Enrollment
Japan
|
1 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
|
Elevated Serum Alpha-Fetoprotein (AFP)
|
0 Participants
n=3 Participants • Participants with AFP data
|
3 Participants
n=6 Participants • Participants with AFP data
|
3 Participants
n=9 Participants • Participants with AFP data
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who received treatment
Local progression event: occurring in the treated hepatic lesion.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Number of Participants With a Local Progression Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Participants who received treatment
The time to freedom from extra hepatic progression will be estimated by competing risk models with death as a competing risk. Risk factors such as tumor size and institution will be tested in a multivariate Cox regression model adjusting for the competing risks.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Comparison of Median Freedom From Extra Hepatic Progression
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Participants who received treatment
Extra hepatic PFS within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Participants who received treatment
FFLP within each subgroup will be summarized by cumulative incidence function estimators adjusted for the competing risk of death or regional or distant progression.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Time from randomization until death from any cause, assessed up to 3 yearsPopulation: Participants who received treatment
Overall survival will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula. Log rank tests will be used to compare treatment groups. Cox proportional hazard models will be used to estimate hazard ratios between treatment groups and to assess other risk factors, in particular the effect of tumor size and the impact of the different institutions.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Median OS
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Participants who received treatment
Within each subgroup OS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals calculated using Greenwood's formula.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Median OS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Randomization through 3 yearsPopulation: Participants who received treatment
Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Number of Participants With Disease Progression or Death
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Randomization through 18 monthsPopulation: Participants who receive treatment
Including local, regional, or distant progression events, or death. Local progression event: occurring in the treated tumor. Regional progression event: occurring in the same part of the body as the treated tumor. Distant progression event: occurring outside the region of the body where the treated tumor is located.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Number of Participants With Disease Progression or Death by Tumor Size (<= 3 cm and > 3 cm) Per Treatment Group
<= 3 cm
|
1 Participants
|
2 Participants
|
|
Number of Participants With Disease Progression or Death by Tumor Size (<= 3 cm and > 3 cm) Per Treatment Group
> 3 cm
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Participants who received treatment
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Freedom From Local Progression (FFLP)
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Participants who received treatment
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Progression-free Survival (PFS)
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Participants who received treatment
The impact of elevated AFP level on time to event endpoints: FFLP, PFS, extra hepatic PFS and OS will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Extra Hepatic PFS
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Participants who received treatment
The impact of elevated AFP level on time to event endpoints will be evaluated both in terms of the initial AFP level and on-study levels in a Cox proportional hazards model.
Outcome measures
| Measure |
Transarterial Chemoembolization (TACE)
n=4 Participants
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 Participants
Patients undergo image-guided SBRT.
|
|---|---|---|
|
The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Overall Survival (OS)
|
NA months
Not calculable due to an insufficient number of events
|
NA months
Not calculable due to an insufficient number of events
|
Adverse Events
Transarterial Chemoembolization (TACE)
Stereotactic Body Radiation Therapy (SBRT)
Serious adverse events
| Measure |
Transarterial Chemoembolization (TACE)
n=6 participants at risk
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 participants at risk
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
Other adverse events
| Measure |
Transarterial Chemoembolization (TACE)
n=6 participants at risk
Patients undergo TACE using an embolic agent.
|
Stereotactic Body Radiation Therapy (SBRT)
n=6 participants at risk
Patients undergo image-guided SBRT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Up to 3 years
|
66.7%
4/6 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
GI disorder other
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Fatigue
|
50.0%
3/6 • Up to 3 years
|
50.0%
3/6 • Up to 3 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatic Pain
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Investigations
Alkaline Phosphatase increased
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Investigations
ALT
|
16.7%
1/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
AST increased
|
33.3%
2/6 • Up to 3 years
|
66.7%
4/6 • Up to 3 years
|
|
Investigations
Blood Bilirubin increased
|
16.7%
1/6 • Up to 3 years
|
66.7%
4/6 • Up to 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
INR increased
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Up to 3 years
|
100.0%
6/6 • Up to 3 years
|
|
Investigations
WBC decreased
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Investigations
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place