Trial Outcomes & Findings for Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer (NCT NCT01164202)
NCT ID: NCT01164202
Last Updated: 2022-03-18
Results Overview
The number of patients with at least one bleed and/or liver failure by treatment group
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
78 participants
Primary outcome timeframe
Up to 7 days following each TACE, up to 5 months of treatment
Results posted on
2022-03-18
Participant Flow
78 patients were included by 17 centers
Participant milestones
| Measure |
Placebo
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Sunitinib
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Sunitinib
n=39 Participants
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
n=39 Participants
|
65.97 years
n=39 Participants
|
66.44 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
36 Participants
n=39 Participants
|
71 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
39 participants
n=39 Participants
|
39 participants
n=39 Participants
|
78 participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days following each TACE, up to 5 months of treatmentPopulation: Intent to treat modified population
The number of patients with at least one bleed and/or liver failure by treatment group
Outcome measures
| Measure |
Placebo
n=34 Participants
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Sunitinib
n=36 Participants
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
|---|---|---|
|
Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure
|
5.88 percentage of participants
Interval 0.72 to 19.68
|
2.78 percentage of participants
Interval 0.07 to 14.53
|
SECONDARY outcome
Timeframe: From randomization until death or last news for alive patients, up to 3 yearsOverall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
Outcome measures
| Measure |
Placebo
n=38 Participants
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Sunitinib
n=39 Participants
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
|---|---|---|
|
Overall Survival
|
20.5 Months
Interval 15.1 to 30.6
|
25 Months
Interval 13.5 to 36.8
|
SECONDARY outcome
Timeframe: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came firstDisease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.
Outcome measures
| Measure |
Placebo
n=38 Participants
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
Sunitinib
n=39 Participants
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: Chemoembolisation
|
|---|---|---|
|
Disease-free Survival
|
5.5 Months
Interval 4.1 to 7.8
|
9 Months
Interval 5.8 to 11.6
|
Adverse Events
Sunitinib
Serious events: 14 serious events
Other events: 27 other events
Deaths: 32 deaths
Placebo
Serious events: 13 serious events
Other events: 36 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Sunitinib
n=39 participants at risk
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: chemoembolization
|
Placebo
n=38 participants at risk
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: chemoembolization
|
|---|---|---|
|
General disorders
Asthenia
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
General disorders
Fever
|
7.7%
3/39 • Up to the end of treatment, on the average of 36 months
|
5.3%
2/38 • Up to the end of treatment, on the average of 36 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
7.9%
3/38 • Up to the end of treatment, on the average of 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Ascite
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Black stool
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Neutrophiles
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Platelets
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Vascular disorders
Encephalopathy
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Bilirubin
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Hepatic disorder
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Cardiac disorders
Endocardite
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
Other adverse events
| Measure |
Sunitinib
n=39 participants at risk
sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: chemoembolization
|
Placebo
n=38 participants at risk
placebo 3cps/days 4 weeks over 6 during 1 year
Placebo: placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization: chemoembolization
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
4/39 • Up to the end of treatment, on the average of 36 months
|
7.9%
3/38 • Up to the end of treatment, on the average of 36 months
|
|
Skin and subcutaneous tissue disorders
Liver pain
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
ALAT
|
20.5%
8/39 • Up to the end of treatment, on the average of 36 months
|
18.4%
7/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
ASAT
|
20.5%
8/39 • Up to the end of treatment, on the average of 36 months
|
44.7%
17/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Increase GGT
|
7.7%
3/39 • Up to the end of treatment, on the average of 36 months
|
15.8%
6/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Bilirubine
|
25.6%
10/39 • Up to the end of treatment, on the average of 36 months
|
13.2%
5/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Liver failure
|
12.8%
5/39 • Up to the end of treatment, on the average of 36 months
|
10.5%
4/38 • Up to the end of treatment, on the average of 36 months
|
|
Hepatobiliary disorders
Phosphatases alcalines
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
7.9%
3/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Hemoglobine
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
5.3%
2/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Leucocytose
|
15.4%
6/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Neutrophiles
|
28.2%
11/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Platelets
|
30.8%
12/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Vascular disorders
Arterial hypertension
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
10.5%
4/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Anorexia
|
7.7%
3/39 • Up to the end of treatment, on the average of 36 months
|
2.6%
1/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Ascite
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
General disorders
Asthenia
|
23.1%
9/39 • Up to the end of treatment, on the average of 36 months
|
5.3%
2/38 • Up to the end of treatment, on the average of 36 months
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/39 • Up to the end of treatment, on the average of 36 months
|
5.3%
2/38 • Up to the end of treatment, on the average of 36 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
12.8%
5/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
|
Blood and lymphatic system disorders
Prothrombin time
|
2.6%
1/39 • Up to the end of treatment, on the average of 36 months
|
5.3%
2/38 • Up to the end of treatment, on the average of 36 months
|
|
Vascular disorders
Encephalopathia
|
5.1%
2/39 • Up to the end of treatment, on the average of 36 months
|
0.00%
0/38 • Up to the end of treatment, on the average of 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place