OncoMatch/Clinical Trials/NCT05435014
T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma
Is NCT05435014 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including T-ACE Oil and Lipiodol for hepatocellular carcinoma.
Treatment: T-ACE Oil · Lipiodol — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage VERY EARLY STAGE, INTERMEDIATE STAGE (BCLC (2018 AASLD))
In very early stage to intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦ 10, HCC tumor size ≦ 15 centimeters
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: TACE
Exception: Patients who have ever accepted TACE therapy, and cannot gain extra benefits from further embolization treatment.
Patients, who have ever accepted TACE therapy, and cannot gain extra benefits from further embolization treatment.
Lab requirements
Blood counts
Absolute Neutrophil Count ≥ 1000/μL; Platelets ≥ 50,000/μL; Hgb ≥ 8.5 g/dL
Kidney function
eGFR ≥ 50 ml/min/1.73m2 and creatinine ≤ 1.5x ULN; not planned for renal replacement therapy during treatment
Liver function
Child-Pugh score ≤ 8; AST ≤ 5x ULN; ALT ≤ 5x ULN; Total Bilirubin ≤ 2 mg/dL; no evidence of decompensation (ascites, bleeding, encephalopathy, severe infection)
Cardiac function
No heart failure (NYHA III/IV), no marked baseline prolongation of QT/QTc interval (>480 ms), no history of risk factors for torsades de pointes, no major cardiovascular disease (stroke, TIA)
Child-Pugh score ≤ 8; AST ≤ 5x ULN; ALT ≤ 5x ULN; Total Bilirubin ≤ 2 mg/dL; eGFR ≥ 50 ml/min/1.73m2 and creatinine ≤ 1.5x ULN; Absolute Neutrophil Count ≥ 1000/μL; Platelets ≥ 50,000/μL; Hgb ≥ 8.5 g/dL; No heart failure (NYHA III/IV), no marked baseline prolongation of QT/QTc interval (>480 ms), no history of risk factors for torsades de pointes, no major cardiovascular disease (stroke, TIA)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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