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Completed

NCT Number: NCT06265883

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Len+DEB-TACE+HAIC

Procedure

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

Procedure

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.

Primary outcomes

  1. Time to progression (TTP)

    Time frame: 3.5 years

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

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: 3.5 years

    defined as the percentage of patients with complete or partial response

  2. Disease control rate (DCR)

    Time frame: 3.5 years

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

  3. overall survival

    Time frame: 3.5 years

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

  4. treatment-related adverse events (TRAEs)

    Time frame: 3.5 years

    assessed based on Common Terminology Criteria for Adverse Events version 5.0

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Affiliated Hospital of Guangdong Medical University
  • Affiliated Hospital of Nanjing University of Chinese Medicine
  • First People's Hospital of Foshan
  • Guangzhou Development District Hospital
  • Huizhou Municipal Central Hospital
  • Jieyang People's Hospital
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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