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Hepatocellular Carcinoma Non-resectableNCT06265883

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

An observational study of Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma Non-resectable
What is being tested?
Len+DEB-TACE+HAIC and Len+DEB-TACE
How many people
205 participants
Where
1 siteChina
Study dates
1 Jul 2019to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with large HCC and PVTT.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Len+DEB-TACE+HAIC, Len+DEB-TACE
Keywords
Hepatocellular Carcinoma, Lenvatinib, transarterial chemoembolization, drug-eluting bead, hepatic arterial infusion chemotherapy, portal vein tumor thrombosis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Len+DEB-TACE+HAICProcedure or surgery

    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 or surgery

    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.

Study groups in NCT06265883
Study groupRoleWhat they receive
Len+DEB-TACE+HAICPatients were treated with Len+DEB-TACE+HAIC.
Receives: Procedure: Len+DEB-TACE+HAIC
Len+DEB-TACEPatients were treated with Len+DEB-TACE.
Receives: Procedure: Len+DEB-TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression (TTP)

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

    Measured: 3.5 years

Secondary outcomes (4)

  1. objective response rate (ORR)

    defined as the percentage of patients with complete or partial response

    Measured: 3.5 years

  2. Disease control rate (DCR)

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

    Measured: 3.5 years

  3. overall survival

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

    Measured: 3.5 years

  4. treatment-related adverse events (TRAEs)

    assessed based on Common Terminology Criteria for Adverse Events version 5.0

    Measured: 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06265883
Sponsor's protocol ID
MIIR-16-Retro
Status last verified
Feb 2024
First submitted
10 Feb 2024
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38869974

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (TTP) (time frame: 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06265883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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