Trial Outcomes & Findings for Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC (NCT NCT02670122)

NCT ID: NCT02670122

Last Updated: 2021-03-30

Results Overview

Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres

• Recruitment status: COMPLETED
• Target enrollment: 131 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-03-30

Participant Flow

Prospective inclusion from march 2015 to november 2016 in 10 University Hospitals

Participant milestones

Measure	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.
Overall Study STARTED	131
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

Baseline characteristics by cohort

Measure	Patients With Non Resectable HCC n=131 Participants 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.
Age, Continuous	68.64 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	128 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	131 Participants n=5 Participants
Region of Enrollment Europe	131 Participants n=5 Participants
Technical success rate	214 DEB-TACE procedures n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Major Complications n=131 Participants Common Terminology Criteria for Adverse Events 4.03 grade 3 or 4 adverse events	Minor Complications n=131 Participants Common Terminology Criteria for Adverse Events 4.03 grade 1 or 2 adverse events	Procedure Related Mortality n=131 Participants Patients that died due to the DEB-TACE procedure	Severe PES n=131 Participants Severe Post Embolisation Syndrome is when due to the pain and/or fever caused by the DEB TACE procedure requires intravenous analgesia and extend hospital admission.
Safety and Tolerability	9 Participants	29 Participants	0 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Major Complications n=118 Participants Common Terminology Criteria for Adverse Events 4.03 grade 3 or 4 adverse events	Minor Complications n=94 Participants Common Terminology Criteria for Adverse Events 4.03 grade 1 or 2 adverse events	Procedure Related Mortality n=61 Participants Patients that died due to the DEB-TACE procedure	Severe PES Severe Post Embolisation Syndrome is when due to the pain and/or fever caused by the DEB TACE procedure requires intravenous analgesia and extend hospital admission.
Tumor Response	90 Participants	42 Participants	27 Participants	—

SECONDARY outcome

Timeframe: 2 years

Population: Patients that completed 2 year follow up. Patients losf for FU and the patients who recieved recieved liver transplantation are censored.

Overall survival

Outcome measures

Measure	Major Complications n=109 Participants Common Terminology Criteria for Adverse Events 4.03 grade 3 or 4 adverse events	Minor Complications Common Terminology Criteria for Adverse Events 4.03 grade 1 or 2 adverse events	Procedure Related Mortality Patients that died due to the DEB-TACE procedure	Severe PES Severe Post Embolisation Syndrome is when due to the pain and/or fever caused by the DEB TACE procedure requires intravenous analgesia and extend hospital admission.
OS	22 months Interval 13.0 to 24.0	—	—	—

Adverse Events

Adverse Events

Serious events: 9 serious events

Other events: 29 other events

Deaths: 48 deaths

Serious adverse events

Measure	Adverse Events n=131 participants at risk Mortality, minor and major adverse events after Tandem-100 DEB-TACE were assessed in accordance with CTCAE 4.03 criteria
Hepatobiliary disorders Hepatic Abcess	2.3% 3/131 • Number of events 3 • 2 years CTCAE 4.03 criteria
Hepatobiliary disorders Cholecistitis, conservative management	1.5% 2/131 • Number of events 2 • 2 years CTCAE 4.03 criteria
Respiratory, thoracic and mediastinal disorders Worsening of a severe COPD	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
Gastrointestinal disorders Colitis	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
General disorders HCC rupture and bleeding. Embolization 10h after TACE	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
General disorders SIRS systemic inflammatory response syndrome, CKD chronic kidney disease. ICU	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria

Other adverse events

Measure	Adverse Events n=131 participants at risk Mortality, minor and major adverse events after Tandem-100 DEB-TACE were assessed in accordance with CTCAE 4.03 criteria
General disorders Severe PES	9.2% 12/131 • Number of events 12 • 2 years CTCAE 4.03 criteria
Hepatobiliary disorders Asymptomatic segmentary bile duct/biliary tree dilatation	6.1% 8/131 • Number of events 8 • 2 years CTCAE 4.03 criteria
Vascular disorders Asymtomatic segmental hepatic artery dissection	1.5% 2/131 • Number of events 2 • 2 years CTCAE 4.03 criteria
Vascular disorders big groing hematoma	1.5% 2/131 • Number of events 2 • 2 years CTCAE 4.03 criteria
Hepatobiliary disorders Biloma. Conservative treatment.	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
Vascular disorders Asymptomatic coagulative thrombosis of a segmental portal branch (LWH)	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
Vascular disorders Asymptomatic segmental hepatic artery perforation	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
General disorders Partial alopecia	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria
Vascular disorders Periumbilical bruise (non target falciform artery embolization)	0.76% 1/131 • Number of events 1 • 2 years CTCAE 4.03 criteria

Additional Information

Jose Urbano Garcia, MD, PhD, EBIR, FCIRSE

Ramon y Cajal University Hospital. Vascular and Interventional Radiology Service

Phone: + 34 606 31 84 30

Email: jurbano34@gmail.com ; jurbano@salud.madrid.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place