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

Hepatocellular Carcinoma Non-resectable Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06265883
• Other study ID #: MIIR-16-Retro
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

Procedure:
• Len+DEB-TACE+HAIC
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-TACE
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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University	Affiliate Hospital of Guangdong Medical University, First People's Hospital of Foshan, Guangzhou Development District Hospital, Huizhou Municipal Central Hospital, Jieyang People's Hospital, Shenzhen Traditional Chinese Medicine Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP)	defined as the time from treatment initiation to the first occurrence of disease progression.	3.5 years
Secondary	objective response rate (ORR)	defined as the percentage of patients with complete or partial response	3.5 years
Secondary	Disease control rate (DCR)	defined as the percentage of patients with complete or partial response, or stable disease	3.5 years
Secondary	overall survival	defined as the time from treatment initiation until death from any reason.	3.5 years
Secondary	treatment-related adverse events (TRAEs)	assessed based on Common Terminology Criteria for Adverse Events version 5.0	3.5 years