Trial Outcomes & Findings for Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC (NCT NCT00576056)
NCT ID: NCT00576056
Last Updated: 2017-02-15
Results Overview
Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 24 months (from initial treatment through 12 months follow-up)
Results posted on
2017-02-15
Participant Flow
Participant milestones
| Measure |
Tace + Sorafenib
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Tace + Sorafenib
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
did not meet eligibility criteria
|
8
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC
Baseline characteristics by cohort
| Measure |
Tace + Sorafenib
n=19 Participants
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months (from initial treatment through 12 months follow-up)Population: Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).
Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Tace + Sorafenib
n=6 Participants
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality
|
174.00 days
Interval 0.0 to 427.355
|
SECONDARY outcome
Timeframe: From date of initial treatment until the date of death from any causePopulation: Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).
Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.
Outcome measures
| Measure |
Tace + Sorafenib
n=6 Participants
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Determine the Overall Survival in Patients Treated With This Combination Regimen
|
156.000 days
Interval 0.0 to 991.374
|
Adverse Events
Tace + Sorafenib
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tace + Sorafenib
n=19 participants at risk
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Renal and urinary disorders
renal failure
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
Other adverse events
| Measure |
Tace + Sorafenib
n=19 participants at risk
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
|
|---|---|
|
Investigations
Increased ALT
|
21.1%
4/19 • Number of events 4
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Blood and lymphatic system disorders
Increased AST
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Fatigue
|
36.8%
7/19 • Number of events 7
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • Number of events 3
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Increased GGTP
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
leukopenia
|
15.8%
3/19 • Number of events 3
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
thrombocytopenia
|
21.1%
4/19 • Number of events 4
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Increased total bilirubin
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
nausea
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Hiccups
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Increased Alkaline Phosphatase
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Hypophosphatemia
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Increased Lipase
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.1%
4/19 • Number of events 4
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Hoarseness
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Abdominal Pain
|
26.3%
5/19 • Number of events 5
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • Number of events 3
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Tremors
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Investigations
Weight Loss
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Infections and infestations
Urinary Tract Infection
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Psychiatric disorders
Hallucination
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Infections and infestations
Mouth Infection
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.8%
3/19 • Number of events 3
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Decreased Serum Albumin
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.6%
6/19 • Number of events 6
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Bloating
|
10.5%
2/19 • Number of events 2
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
15.8%
3/19 • Number of events 3
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Reproductive system and breast disorders
Breast Tenderness
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Bleeding oral cavity
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Renal and urinary disorders
Increased urination
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Difficulty swallowing
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
Bleeding varices
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
General disorders
Lower Extremity Edema
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Musculoskeletal and connective tissue disorders
Incisional hernia
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Cardiac disorders
Cardiac Arrhythmia
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Gastrointestinal disorders
dehydration
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Metabolism and nutrition disorders
Elevated Amylase
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
|
Renal and urinary disorders
Creatinine
|
5.3%
1/19 • Number of events 1
Regular investigator assessment and laboratory testing in addition to participant self reporting
|
Additional Information
Dr. David Geller
University of Pittsburgh Medical Center
Phone: 412-692-2001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place