Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC

Last updated: May 24, 2024
Sponsor: Sun Yat-sen University
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Abdominal Cancer

Cancer/tumors

Treatment

Lenvatinib

Clinical Study ID

NCT06435013
LenBev-001
  • Ages > 18
  • All Genders

Study Summary

Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors [lenvatinib] and anti-VEGF antibody [bevacizumab]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.

Eligibility Criteria

Inclusion

Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin <30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -

Exclusion

Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.

Study Design

Total Participants: 208
Treatment Group(s): 1
Primary Treatment: Lenvatinib
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
May 20, 2024

Connect with a study center

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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