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
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.
• Age of over 20 years (or according to local legal definition of majority).
• Patients diagnosed of HCC (Meet at least ONE of the following criteria):
• A. Diagnosed via tumor biopsy by pathologists and confirmed by on-service physician.
• B. High risk patients (viral hepatitis B or C or cirrhotic) with typical liver cancer image appeared on MRI or CT scan.
• In very early stage to intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦ 10, HCC tumor size ≦ 15 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score\[1\] ≦ 8.
• Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
• Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
• Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound) and non-treated before.
• May have received local therapy such as TAE, TACE, radiofrequency ablation (RFA) or surgery and remain eligible for study provided the prior therapy was within the following timeframes and the subject has fully recovered from prior therapy:
• A. TAE/TACE: more than 8 weeks since completion of prior therapy B. RFA: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results.
• C. Surgery: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results.
• Patients able to understand, willing to accept and cooperate with all clinical trial practices.
• Willing to sign a written informed consent form.