Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT

Completed

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Procedure: Len+DEB-TACE; Procedure: Len+DEB-TACE+HAIC

• Registration Number: NCT06265883
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups.

Detailed Description

Consecutive patients with large HCC and PVTT treated with lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) or lenvatinib plus DEB-TACE (Len+DEB-TACE) from July 2019 to June 2021 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Clinical outcomes, including tumor response, TTP, OS, and TRAEs were compared between the two groups.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-10
• Study First Submitted QC: 2024-02-10
• Last Update Submitted: 2024-02-10
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• a confirmed diagnosis of HCC
• the largest intrahepatic lesion >7 cm
• presence of major PVTT on imaging
• Eastern Cooperative Oncology Group performance status ≤1
• Child-Pugh class A/B
• adequate hematologic and organ function, with leukocyte count 3.0 109/L, neutrophil count 1.5 109/L, platelet count 75 109/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase 5 upper limit of the normal, creatinine clearance rate 1.5 upper limit of the normal, and prothrombin time prolongation <4 s

Exclusion Criteria

• incomplete medical records
• central nervous system involvement
• previous treatment with transarterial embolization, TACE, HAIC, radiotherapy, or systemic therapy
• history of malignancies other than HCC
• history of organ transplantation
• severe cardiac, pulmonary or renal dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Len+DEB-TACE	Len+DEB-TACE	Patients were treated with Len+DEB-TACE.
Len+DEB-TACE+HAIC	Len+DEB-TACE+HAIC	Patients were treated with Len+DEB-TACE+HAIC.

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP)	3.5 years	defined as the time from treatment initiation to the first occurrence of disease progression.

Secondary Outcome Measures

Name	Time	Method
treatment-related adverse events (TRAEs)	3.5 years	assessed based on Common Terminology Criteria for Adverse Events version 5.0
overall survival	3.5 years	defined as the time from treatment initiation until death from any reason.
objective response rate (ORR)	3.5 years	defined as the percentage of patients with complete or partial response
Disease control rate (DCR)	3.5 years	defined as the percentage of patients with complete or partial response, or stable disease

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China