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Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC

NCT04241523 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-27

No results posted yet for this study

Summary

Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to assess efficacy and safety of lenvatinib as a preoperative conversion therapy in patients with potentially resectable HCC. Investigator hypothesized that lenvatinib may be an effective conversion treatment for HCC, and preoperative treatment with lenvatinib can improve resectability in patients with potential resectable HCC and improve the long term survival.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Lenvatinib 4 mg Oral

Planned doses of 8 mg of lenvatinib per day for patients with body weight \<60 kg, and 12 mg for those with body weight ≥60 kg. In case of treatment-related adverse effects, interruption or reduction is allowed.

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • West China Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jian Zhou · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-10-31
Completion
2022-02-28

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 NCT04241523 on ClinicalTrials.gov