Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, TACE
Brief summary
This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC). The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.
Detailed description
In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained.
Interventions
DEVICEDEB-TACE
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria 2. Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice. 3. Able and willing to participate and give their written informed consent. 4. Both genders and ≥ 18 years old. 5. Eastern Cooperative Oncology Group (ECOG) 0 6. Preserved hepatic function (Child-Pugh ≤ B7). 7. No evidence of tumoral invasion in portal vein or main biliary ducts. 8. Able to go through image diagnostic techniques such as CT or MRI. 9. Preserved cardiac and renal function. 10. No concomitant active infections that require antibiotic treatment. 11. Measurable disease according to mRECIST criteria. 12. Life expectancy over 6 months.
Exclusion criteria
1. ECOG ≥ 1 2. Child-Pugh ≥B8. 3. Presence of ascitis or encephalopathy 4. Extrahepatic tumoral disease. 5. Tumoral vascular invasion 6. Serum bilirubin\>3 mg/dl. 7. Cr Clearance ≤ 60 ml/min 8. If any of the following is contraindicated: 1. Administration of doxorubicin 2. Iodated contrasts 3. CT or MRI procedures 4. Transarterial embolization procedures 5. White blood cells (WBC) \< 2000 /mm3 6. Neutrophil count \< 1500 /mm3 7. Ejection fraction \< 50 % 8. Platelet count \< 5 x 104/mm3, international normalized ratio (INR) \> 2,0) 9. Transaminases (AST and/or ALT) \> 5x upper limit of normal or \>250 u/l 10. Known hepatofugal portal vein flow 11. A-V intrahepatic macroscopic fistula 9. Pregnant or breast feeding women. 10. Tumor burden involving more than 50% of the liver. 11. Active bacterial or fungal infection. 12. Other concomitant tumors. 13. Any other condition that according to investigator criteria, contraindicates DEB-TACE. 14. Patients not willing to participate and/or give their written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 30 days | Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | 6 months, 1 year, 2 year | Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU. |
| OS | 2 years | Overall survival |
Countries
Spain
Participant flow
Recruitment details
Prospective inclusion from march 2015 to november 2016 in 10 University Hospitals
Participants by arm
| Arm | Count |
|---|---|
| Patients With Non Resectable HCC DEB-TACE with doxorubicin eluting 100 µ microspheres
DEB-TACE: Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Patients With Non Resectable HCC |
|---|---|
| Age, Continuous | 68.64 years STANDARD_DEVIATION 10.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 128 Participants |
| Region of Enrollment Europe | 131 Participants |
| Region of Enrollment Spain | 131 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 103 Participants |
| Technical success rate | 214 DEB-TACE procedures |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 48 / 131 |
| other Total, other adverse events | 29 / 131 |
| serious Total, serious adverse events | 9 / 131 |
Outcome results
Primary
Safety and Tolerability
Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Major Complications | Safety and Tolerability | 9 Participants |
| Minor Complications | Safety and Tolerability | 29 Participants |
| Procedure Related Mortality | Safety and Tolerability | 0 Participants |
| Severe PES | Safety and Tolerability | 12 Participants |
Secondary
OS
Overall survival
Time frame: 2 years
Population: Patients that completed 2 year follow up. Patients losf for FU and the patients who recieved recieved liver transplantation are censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Major Complications | OS | 22 months |
Secondary
Tumor Response
Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.
Time frame: 6 months, 1 year, 2 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Major Complications | Tumor Response | 90 Participants |
| Minor Complications | Tumor Response | 42 Participants |
| Procedure Related Mortality | Tumor Response | 27 Participants |