Transarterial Chemoembolization Combined With Sorafenib/Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail

  • End date
    Jan 8, 2025
  • participants needed
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 10 October 2022


This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with sorafenib/lenvatinib and iodion-125 seeds brachytherapy (TACE-MKI-I) compared with TACE combined with sorafenib/lenvatinib (TACE-MKI) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).


This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-MKI-I compared with TACE-MKI for the treatment of HCC with branch PVTT.

171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-MKI-I or TACE-MKI using an 2:1 randomization scheme.

TACE will be performed for the patients after randomization. Either sorafenib (400mg P.O. BID) or lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE according to the patients' own will and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-MKI-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Condition Hepatocellular Carcinoma Non-resectable
Treatment TACE combined with sorafenib/lenvatinib and iodion-125 seeds brachytherapy, TACE combined with sorafenib/lenvatinib
Clinical Study IdentifierNCT04967495
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on10 October 2022


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Inclusion Criteria

Age between18 and 75 years
HCC confirmed by histopathology and/or cytology, or diagnosed clinically
Accompanied with tumor thrombus involving unilateral portal vein branch
Child-Pugh class A or B
Eastern Cooperative Group performance status (ECOG) score of 0-2
Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L
Prothrombin time prolonged for less than 4s or international normalized ratio < 1.7
Neutrophilic granulocyte count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L, and hemoglobin level ≥ 85g/L
At least one measurable intrahepatic target lesion
Life expectancy of at least 3 months

Exclusion Criteria

Diffuse HCC
Extrahepatic metastasis
Tumor thrombus involving both the left and right branch of portal vein or main portal vein
Hepatic vein and/or vena cava invasion
History of organ or cells transplantation
Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy
History of other malignancies
Serious medical comorbidities
Female patients who are pregnancy or breastfeeding
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