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

Second Affiliated Hospital of Guangzhou Medical University205 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

205

Conditions

Hepatocellular Carcinoma Non-resectable

Interventions

Len+DEB-TACE+HAICPROCEDURE

Patients received TACE with drug-eluting beads and FOLFOX-HAIC. DEB-TACE and/or HAIC was repeated for viable tumors demonstrated by follow-up imaging in patients without worsening liver function or contraindications. Lenvatinib was orally administered at a dose of 12 mg/day (bodyweight 60 kg) or 8mg/day (bodyweight \<60 kg). It was initiated within 7 days after the first DEB-TACE or DEB-TACE+HAIC and continued until unacceptable toxicity or disease progression occurred.

Len+DEB-TACEPROCEDURE

Patients received TACE with drug-eluting beads. DEB-TACE was repeated for viable tumors demonstrated by follow-up imaging in patients without worsening liver function or contraindications. Lenvatinib was orally administered at a dose of 12 mg/day (bodyweight 60 kg) or 8mg/day (bodyweight \<60 kg). It was initiated within 7 days after the first DEB-TACE or DEB-TACE+HAIC and continued until unacceptable toxicity or disease progression occurred.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Time to progression (TTP)

defined as the time from treatment initiation to the first occurrence of disease progression.

Time frame: 3.5 years

Secondary Outcomes

objective response rate (ORR)

defined as the percentage of patients with complete or partial response

Time frame: 3.5 years

Disease control rate (DCR)

defined as the percentage of patients with complete or partial response, or stable disease

Time frame: 3.5 years

overall survival

defined as the time from treatment initiation until death from any reason.

Time frame: 3.5 years

treatment-related adverse events (TRAEs)

assessed based on Common Terminology Criteria for Adverse Events version 5.0

Time frame: 3.5 years

Data from ClinicalTrials.gov

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