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T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma

NCT05435014 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • T-ACE Medical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Po-Chin Liang, PhD, MD · National Taiwan University Hospital

  • Xi-Zhang Lin, MD · T-ACE Medical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435014 on ClinicalTrials.gov