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

February 10, 2024 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • The second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with large HCC and PVTT.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Len+DEB-TACE+HAIC
Patients were treated with Len+DEB-TACE+HAIC.
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 were treated with Len+DEB-TACE.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression (TTP)
Time Frame: 3.5 years
defined as the time from treatment initiation to the first occurrence of disease progression.
3.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-16-Retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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