Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Trial statusRecruiting
Trial phasePhase 2
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 sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+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
accompanied with vena cava tumor thrombus
central nervous system involvement
previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
Trial design
Treatments tested in this trial
- LEN+SIN+DEB-TACE+HAIC
- LEN+SIN+DEB-TACE
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Affiliated Hospital of Guangdong Medical University
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Jieyang People's Hospital
Collaborator
Guangzhou Development District Hospital
Collaborator
First People's Hospital of Foshan
Collaborator
Anqing Municipal Hospital
Collaborator
Jinan University Affiliated Shunde Hospital
Collaborator
Source ClinicalTrials.gov