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

  • STATUS
    Recruiting
  • End date
    Jan 8, 2025
  • participants needed
    171
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 10 October 2022

Summary

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).

Description

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.

Details
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

Eligibility

Yes No Not Sure

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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