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T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma
Sponsor: T-ACE Medical Co., Ltd
Summary
The phase I/II, double-blind, randomized study will investigate the efficacy and safety of TACE/TAE treatment with T-ACE Oil in patients with unresectable hepatocellular carcinoma.
Official title: Phase I/II Randomized, Double-Blind, First-in-Human Study of T-ACE Oil by Trans-Catheter Arterial Embolization or ChemoEmbolization (TAE/TACE) in Patients With Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2022-09-13
Completion Date
2026-06-30
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
T-ACE Oil
TAE/TACE treatment was performed with T-ACE Oil. The volume of T-ACE Oil injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with T-ACE Oil, the remaining volume administered will be study product only.
Lipiodol
TAE/TACE treatment was performed with Lipiodol®. The volume of Lipiodol® injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with Lipiodol®, the remaining volume administered will be study product only.
Locations (4)
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Tungs' Taichung Metroharbor Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan