Trial Outcomes & Findings for Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients (NCT NCT03007225)

NCT ID: NCT03007225

Last Updated: 2020-10-22

Results Overview

Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.")

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-10-22

Participant Flow

Recruitment finished and study completed Patients collected from HCC clinic full filling the inclusion criteria,Ain Shams University hospitals

Participant milestones

Measure	Chemoembolization + Drug Eluting Beads Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter or 2.7F microcatheter	Chemoembolization + Standard TACE Technique Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique Trans-arterial chemoembolization (TACE): TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter . Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. Gel foam embolization was performed then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group 1 n=25 Participants Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) The procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).	Group 2 n=25 Participants Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.	Total n=50 Participants Total of all reporting groups
Age, Continuous	56.7 Years STANDARD_DEVIATION 6.8 • n=25 Participants	56 Years STANDARD_DEVIATION 5.5 • n=25 Participants	56.7 Years STANDARD_DEVIATION 6.8 • n=50 Participants
Sex: Female, Male Female	4 Participants n=25 Participants	3 Participants n=25 Participants	7 Participants n=50 Participants
Sex: Female, Male Male	21 Participants n=25 Participants	22 Participants n=25 Participants	43 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants
50 patients with HCC collected from our weekly HCC clinic, Ain Shams University Hospitals	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants

PRIMARY outcome

Timeframe: 1 year

Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.")

Outcome measures

Measure	Group 1 n=25 Participants Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter	Group 2 n=25 Participants Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
Number of Participants With Complete Response	23 Participants	22 Participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=25 participants at risk Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter	Group 2 n=25 participants at risk Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique :TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performedand an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
Hepatobiliary disorders Deteriorating liver functions after the manouver	4.0% 1/25 • Number of events 1 • 3 months Deterioration of liver functions Bleeding from puncture site Sepsis	20.0% 5/25 • Number of events 5 • 3 months Deterioration of liver functions Bleeding from puncture site Sepsis

Other adverse events

Measure	Group 1 n=25 participants at risk Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) TACE with Drug Eluting Beads procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter	Group 2 n=25 participants at risk Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique :TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performedand an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
Vascular disorders Bleeding from puncture site	0.00% 0/25 • 3 months Deterioration of liver functions Bleeding from puncture site Sepsis	4.0% 1/25 • Number of events 1 • 3 months Deterioration of liver functions Bleeding from puncture site Sepsis

Additional Information

Dr Iman Montasser, Assistant professor of Tropical Medicine member of HCC clinic and group , Ain Sha

Ain Shams University

Phone: 0020201065065333

Email: imanfawzy2@gmail.com

Results disclosure agreements

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