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

NCT06265883 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

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.

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.

Sponsors & Collaborators

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Affiliate Hospital of Guangdong Medical University

    collaborator UNKNOWN

  • Jieyang People's Hospital

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • Guangzhou Development District Hospital

    collaborator UNKNOWN

  • Affiliated Hospital of Nanjing University of Chinese Medicine

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Second Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265883 on ClinicalTrials.gov