Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC

Hepatocellular Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06435013
• Other study ID #: LenBev-001
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 20, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lenvatinib

Intervention

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

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2015-1 to 2023-4