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

Hepatocellular Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Subjects with HCC that meet all eligibility criteria will be admitted to hospital, and TAE or TACE treatment are performed during the hospitalization period; after embolization, subjects are observed in the ward for 1 to 7 days, and evaluated by physician before being discharged. Subjects will be followed up for 7 weeks after treatment for safety and efficacy evaluation.

Phase I part:

12 evaluable subjects will be enrolled sequentially in Phase I part. The first 3 subjects will receive TAE treatment (whether or not they are contraindicated to Doxorubicin) and the following 3 subjects (4th to 6th subjects) will receive TACE treatment. The remaining subjects may receive TAE or TACE treatment. Subjects will be enrolled sequentially in Phase I. For the first six subjects in Phase I, after the subject completes TAE or TACE treatment and is followed for 2 weeks, safety and tolerability data during this period will be reviewed by the safety review committee (SRC); only approved by the SRC, the next subject may start the TAE or TACE treatment. For the 7th to 12th subjects in Phase I, after the subject completes TAE or TACE treatment and is followed until discharge from hospitalization, safety and tolerability data during this period will be reviewed by the safety review committee (SRC); only approved by the SRC, the next subject may start the TAE or TACE treatment. After data for all 12 evaluable subjects are reviewed by SRC and approval is given by the SRC, the study may proceed to Phase II part.

Phase II part:

70 evaluable subjects will be randomized in a 1:1 ratio to receive TAE/TACE treatment by T-ACE Oil or Lipiodol for safety and efficacy evaluation. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT05435014
• Study type: Interventional
• Source: T-ACE Medical Co., Ltd
• Contact: Po-Chin Liang, PI
• Phone: 02-23123456
• Email: e510012@yahoo.com.tw
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 13, 2022
• Completion date: June 30, 2026