Clinical trial NCT06265883: Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT
Official title: Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Large Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: a Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Hepatocellular Carcinoma
Lenvatinib
transarterial chemoembolization
drug-eluting bead
hepatic arterial infusion chemotherapy
portal vein tumor thrombosis
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
name: Affiliate Hospital of Guangdong Medical University
name: Jieyang People's Hospital
name: Huizhou Municipal Central Hospital
name: Guangzhou Development District Hospital
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: First People's Hospital of Foshan
First posted: 2024-02-20
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with large HCC and PVTT.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: 3.5 years
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: 3.5 years
measure: Disease control rate (DCR)
timeFrame: 3.5 years
measure: overall survival
timeFrame: 3.5 years
measure: treatment-related adverse events (TRAEs)
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: