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Completed

NCT Number: NCT06435013

Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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Treatment and study plan

Lenvatinib

Drug

Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

Primary outcomes

  1. progression-free survival

    Time frame: 2015-1 to 2023-4

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Lenvatinib Versus Bevacizumab Combined With Immune Checkpoint Inhibitors and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Retrospective, Multi-center, and Propensity Score Matching Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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