NCT06265883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

February 10, 2024

Last Update Submit

February 10, 2024

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular CarcinomaLenvatinibtransarterial chemoembolizationdrug-eluting beadhepatic arterial infusion chemotherapyportal vein tumor thrombosis

Outcome Measures

Primary Outcomes (1)

  • Time to progression (TTP)

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

    3.5 years

Secondary Outcomes (4)

  • objective response rate (ORR)

    3.5 years

  • Disease control rate (DCR)

    3.5 years

  • overall survival

    3.5 years

  • treatment-related adverse events (TRAEs)

    3.5 years

Study Arms (2)

Len+DEB-TACE+HAIC

Patients were treated with Len+DEB-TACE+HAIC.

Procedure: Len+DEB-TACE+HAIC

Len+DEB-TACE

Patients were treated with Len+DEB-TACE.

Procedure: Len+DEB-TACE

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-TACE+HAIC
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.

Len+DEB-TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with large HCC and PVTT.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Related Publications (1)

  • Cai M, Liang L, Zhang J, Chen N, Huang W, Guo Y, Hong X, Lin L, Liu Y, Dan C, Deng H, Liu X, Zhou J, Chen Y, Chen H, Zhu K. Lenvatinib plus drug-eluting bead transarterial chemoembolization with/without hepatic arterial infusion chemotherapy for hepatocellular carcinoma larger than 7 cm with major portal vein tumor thrombosis: a multicenter retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):7860-7870. doi: 10.1097/JS9.0000000000001819.

    PMID: 38869974DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 20, 2024

Study Start

July 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

CN(1)