Trial Outcomes & Findings for Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (NCT NCT00844883)
NCT ID: NCT00844883
Last Updated: 2021-11-11
Results Overview
Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
6 weeks (Cycle 1)
Results posted on
2021-11-11
Participant Flow
This study enrolled patients diagnosed with unresectable hepatocellular carcinoma who were eligible to receive a combination therapy of sorafenib and transarterial chemoembolization. Enrollment took place from 3/2009 to 12/2011 at Johns Hopkins Hospital.
90 patients consented and screened for study. 38 were ineligible and 2 later declined participation.
Participant milestones
| Measure |
Sorafenib and Drug Eluting Beads
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Patients Who Received TACE
|
48
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sorafenib and Drug Eluting Beads
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Overall Study
Bridged to liver transplant
|
3
|
|
Overall Study
Bridged to resection
|
1
|
Baseline Characteristics
Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (Cycle 1)Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Anemia
|
13 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Lymphopenia
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Thrombocytopenia
|
8 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Arrhythmia
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Chest pain
|
2 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Dissection
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Embolus or coagulopathy
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hypertension
|
7 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Lower extremity edema
|
12 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Fatigue
|
42 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Fever
|
15 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hand-foot skin reaction
|
23 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Mucositis
|
11 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Rash
|
26 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Skin pain
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Ascites
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Anorexia
|
28 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Diarrhea
|
19 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Nausea or vomiting
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Epistaxis or hemoptysis
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hematochezia
|
2 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hematoma
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Tumor rupture
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated ALT level
|
25 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated AST level
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated AP level
|
17 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated amylase level
|
10 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated lipase level
|
15 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated INR level
|
16 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hyperbilirubinemia
|
30 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hypoalbuminemia
|
27 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Infection
|
6 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Dizziness
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Headache
|
9 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Encephalopathy
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Nonspecific abdominal pain
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Musculoskeletal pain
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Right upper quadrant pain
|
24 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Pain - other
|
12 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Acute renal failure
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Death (disease progression)
|
1 # of participants with adverse events
|
PRIMARY outcome
Timeframe: 2 years (Cycles 2-5+)Population: 39 patients were reviewed for toxicities for Cycle 2-5+. 11 patients out of the original 50 exited the study prior to Cycle 2.
Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=39 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Pain - other
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Anemia
|
14 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Lymphopenia
|
19 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Pancytopenia
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Thrombocytopenia
|
11 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Arrhythmia
|
2 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Chest pain
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hypertension
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Lower extremity edema
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Fatigue
|
30 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Fever
|
4 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hand-foot skin reaction
|
20 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Mucositis
|
6 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Rash
|
12 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Skin pain
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Ascites
|
2 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Anorexia
|
14 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Diarrhea
|
15 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Nausea or vomiting
|
13 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Epistaxis or hemoptysis
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Cholangitis
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated ALT level
|
9 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated AST level
|
10 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated AP level
|
15 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated amylase level
|
7 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated lipase level
|
9 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Elevated INR level
|
8 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hyperbilirubinemia
|
11 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Hypoalbuminemia
|
14 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Infection
|
8 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Liver abscess
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Dizziness
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Headache
|
6 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Encephalopathy
|
3 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Nonspecific abdominal pain
|
22 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Musculoskeletal pain
|
17 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Right upper quadrant pain
|
10 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Acute renal failure
|
1 # of participants with adverse events
|
|
Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.
Death (disease progression)
|
2 # of participants with adverse events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 33 out of the original 50 patients were evaluable for this outcome, with 17 out of the original 50 exiting prior to 6 months or were not assessable by RECIST criteria.
Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6 months post the initiation of treatment. 33 out of the original 50 patients were evaluable at this time point, with 17 out of the 50 exiting prior to 6 months or were not assessable by RECIST criteria. Complete response (CR): Disappearance of all lesions targeted with therapy Partial Response (PR): at least 30% decrease in sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): at least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=33 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate
Complete Response
|
1 Participants
|
|
Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate
Partial Response or Stable Disease
|
30 Participants
|
|
Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate
Progressive Disease
|
2 Participants
|
|
Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate
Disease control rate (CR + PR + SD)
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 32 out of the 50 patients had imaging assessable by EASL criteria at 6 months - 18 out of the original 50 had exited prior to this time point or did not have applicable imaging.
Efficacy as assessed by radiographic tumor response using the EASL criteria at baseline and at 6 months post the initiation of treatment. Complete response (CR): 100% tumor necrosis Partial Response (PR): more than 50% tumor necrosis Progressive Disease (PD): increase in tumor enhancement by more than 25% Stable Disease (SD): Cases that do not qualify for one of the above criteria
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=32 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate
Complete Response
|
7 Participants
|
|
Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate
Partial Response
|
15 Participants
|
|
Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate
Stable Disease
|
8 Participants
|
|
Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate
Progressive Disease
|
2 Participants
|
|
Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate
Disease control rate (CR + PR + SD)
|
30 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Median TTP stratified by BCLC staging; 3 patients had BCLC stage A disease, 14 with stage B, and 29 with stage C.
Time to progression (TTP) - defined as the time from initiation of therapy to disease progression (radiological). Median TTP calculated for all subjects and stratified by Barcelona Clinic Liver Cancer (BCLC) staging. 46 patients out of 50 were reviewed for this outcome. 3 patients were excluded because they underwent liver transplantation and 1 patient was excluded for hepatic resection.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=46 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE
Median TTP
|
13.9 months
Interval 8.5 to 27.6
|
|
Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE
Median TTP for BCLC stage A
|
27.6 months
Interval 15.8 to
Number of patients insufficient to determine upper IQR
|
|
Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE
Median TTP for BCLC stage B
|
24.7 months
Interval 13.9 to 26.5
|
|
Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE
Median TTP for BCLC stage C
|
9.5 months
Interval 5.2 to 12.8
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival. All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Efficacy - Overall Survival (OS) After Combination Treatment With Sorafenib and TACE
|
20.4 months
Interval 7.2 to 34.0
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE
Median liver tumor burden >10%
|
2.60 Hazard ratio
Interval 1.38 to 4.9
|
|
Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE
Median tumor size > 10cm
|
2.12 Hazard ratio
Interval 1.06 to 4.21
|
|
Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE
ECOG performance status
|
2.45 Hazard ratio
Interval 1.3 to 4.62
|
|
Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE
BCLC stage
|
2.49 Hazard ratio
Interval 1.39 to 4.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib.
Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Estimated Percentage of Participants Surviving After One Year
|
64 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib.
Percentage of study patients surviving after three years from initial treatment analyzed with Kaplan-Meier curve.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Estimated Percentage of Participants Surviving After Three Year
|
19.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 yearsPopulation: 50 total participants received sorafenib on trial. 3 were classified as BCLC A, 16 as BCLC B, and 31 as BCLC C.
Median overall survival stratified by Barcelona Clinic Liver Cancer (BCLC) staging as assessed by Kaplan-Meier estimator. Patients are grouped to stages A (early), B (intermediate), and C (advanced) according to stage of disease.
Outcome measures
| Measure |
Sorafenib and Drug Eluting Beads
n=50 Participants
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Median Overall Survival OS Stratified by BCLC Criteria
BCLC C
|
8.0 months
Interval 1.38 to 34.0
|
|
Median Overall Survival OS Stratified by BCLC Criteria
BCLC A
|
45.6 months
Interval 32.4 to 46.0
|
|
Median Overall Survival OS Stratified by BCLC Criteria
BCLC B
|
29.7 months
Interval 12.1 to 34.5
|
Adverse Events
Sorafenib and Drug Eluting Beads
Serious events: 8 serious events
Other events: 50 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Sorafenib and Drug Eluting Beads
n=50 participants at risk
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Non-cardiac chest pain
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Metabolism and nutrition disorders
Elevated creatinine
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Overdose on pain medication
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor rupture
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
Other adverse events
| Measure |
Sorafenib and Drug Eluting Beads
n=50 participants at risk
single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.0%
14/50 • Number of events 27 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Lymhopenia
|
48.0%
24/50 • Number of events 43 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Thrombocytopenia
|
22.0%
11/50 • Number of events 19 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Cardiac disorders
Arrhythmia
|
8.0%
4/50 • Number of events 4 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Vascular disorders
Common hepatic artery dissection
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Vascular disorders
Embolus or coagulopathy
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Edema - lower extremity
|
24.0%
12/50 • Number of events 15 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Fatigue
|
84.0%
42/50 • Number of events 72 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Fever
|
30.0%
15/50 • Number of events 19 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Skin and subcutaneous tissue disorders
Hand foot skin reaction
|
46.0%
23/50 • Number of events 43 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Mucositis
|
22.0%
11/50 • Number of events 17 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.0%
26/50 • Number of events 38 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
8.0%
4/50 • Number of events 7 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Ascites
|
6.0%
3/50 • Number of events 5 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Metabolism and nutrition disorders
Anorexia
|
56.0%
28/50 • Number of events 42 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Diarrhea
|
38.0%
19/50 • Number of events 34 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Nausea or vomiting
|
48.0%
24/50 • Number of events 37 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis or hemoptysis
|
2.0%
1/50 • Number of events 2 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Hematochezia
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Vascular disorders
Hematoma
|
6.0%
3/50 • Number of events 3 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated ALT
|
50.0%
25/50 • Number of events 34 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated AST
|
48.0%
24/50 • Number of events 34 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated AP
|
34.0%
17/50 • Number of events 32 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated amylase
|
20.0%
10/50 • Number of events 17 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated lipase
|
30.0%
15/50 • Number of events 24 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Elevated INR
|
32.0%
16/50 • Number of events 24 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Hyperbilirubinemia
|
60.0%
30/50 • Number of events 41 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Investigations
Hypoalbuminemia
|
54.0%
27/50 • Number of events 41 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Infections and infestations
Infection
|
16.0%
8/50 • Number of events 8 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Liver abscess
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Number of events 5 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Nervous system disorders
Headache
|
18.0%
9/50 • Number of events 15 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Nervous system disorders
Encephalopathy
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Nonspecific abdominal pain
|
46.0%
23/50 • Number of events 45 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal
|
48.0%
24/50 • Number of events 41 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Gastrointestinal disorders
Pain - right upper quadrant
|
48.0%
24/50 • Number of events 34 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
General disorders
Pain - other
|
24.0%
12/50 • Number of events 16 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for the entire duration of study participation, an average of 2 years. Participants remained on study until further treatment with sorafenib and TACE was deemed to not be beneficial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place