Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
Eligibility criteria
Qualifiers
a confirmed diagnosis of HCC
the largest intrahepatic lesion >7 cm
presence of PVTT on imaging
tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
Disqualifiers
Diffuse HCC
accompanied with vena cava tumor thrombus
central nervous system involvement
previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
Trial design
Treatments tested in this trial
- Len+DEB-TACE+HAIC
- Len+DEB-TACE
Treatment groups
178 Participants
are divided into 2 treatment groupsLocations
1The Second Affiliated Hospital of Guangzhou Medical University510260, GuangzhouGuangdong, China
Sponsors and collaborators
Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Source ClinicalTrials.gov