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Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04227808
Collaborator
Tongji Hospital (Other), Anhui Provincial Hospital (Other), West China Hospital (Other)
50
Enrollment
4
Locations
1
Arm
26.6
Anticipated Duration (Months)
12.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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 evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of HCC with a high risk of tumor recurrence.

Investigator hypothesize that lenvatinib may be an effective adjuvant treatment for HCC, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (RFS) of HCC patients after surgical resection.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lenvima 4 mg Oral Capsule
 Phase 2

Detailed Description

There's no widely accepted adjuvant therapy for patients with HCC. Lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved for advanced or unresectable HCC. In this study, investigators aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent curative resection for HCC with high risk of disease recurrence.

Participants who underwent radical resection for HCC with high risk of tumor recurrence will be recruited in this study. During 4 to 6 weeks after surgery, each participant will receive a screening visit to exclude residual tumors. Each eligible participant will be treated with lenvatinib until tumor recurrence, intolerant adverse effect, participant' refusal, or completing 12-month treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Lenvatinib as an Adjuvant Therapy in Patients With Hepatocellular Carcinoma Following Radical Resection: A Single-Arm and Open-Label Prospective Study
Actual Study Start Date :
Dec 12, 2019
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lenvatinib Arm

Experimental: Participants will be given lenvatinib (12 mg/d for body weight≥60kg, 8 mg/d for body weight < 60kg) for 12 months until disease recurrence or intolerance AEs or death.

Drug: Lenvima 4 mg Oral Capsule
The participants will receive treatment with lenvatinib for 12 months after recruitment or until disease recurrence, intolerance AEs, or death. In case of treatment-related adverse effects, interruption or reduction is allowed.
Other Names:
  • Lenvatinib 4 mg Oral Capsule

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1-year RFS rate [1 year after LPI]

      1-year RFS rate is defined as the percentage of patients who do not experience tumor recurrence or death from any cause after 1-year treatment.

    Secondary Outcome Measures

    1. Overall survival (OS) [3 years]

      The duration from the date of first dosage to the date of death from any cause.

    2. Adverse events [13 months]

      An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.

    3. Serious adverse events(SAE) [13 months]

      A serious adverse event (SAE) refers to an event in clinical trials that requires inpatient hospitalization or causes prolongation of existing hospitalization, permanent disability, incapacity, threats to life or death, and birth defect, etc. Number and classification of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 were recorded.

    4. Health-related quality of life [13 months]

      Health-related quality of life questionnaire measured by EORTC QLQ-HCC18.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female patients aged 18-75;

    2. Histological diagnosis of HCC;

    3. Tumor stage before surgery: IIb/IIIa stage (>3 tumor nodules, or vascular invasion) HCC according to China Liver Cancer Staging System (or BCLC B/C/PVTT);

    4. Underwent R0 resection (microscopic or macroscopic tumor clearance) in four to six weeks before recruitment; no residual tumor before recruitment by imaging study (MRI/CT), nor metastases to other organs;

    5. Adequate liver, renal functions;

    6. Written informed consent;

    7. ECOG 0-1 and Child-Pugh A.

    Exclusion Criteria:

    1. WBC<4.010^9/L, HB<80 g/L, and PLT<7510^9/L at blood screening;

    2. Coagulation function: (prothrombin time) international normalized ratio (INR) >2.3, or extension of prothrombin time>6 seconds;

    3. Liver function: serum albumin (ALB)<2.8 g/dl, total bilirubin (TBIL)>51.3μmol/L, alanine aminotransferase and aspartate aminotransferase (ALT and AST)>5 times the upper limit of normal range;

    4. Renal function: serum creatinine (Cr)>1.5 times the upper limit of normal range;

    5. lymph node metastases;

    6. The participant has uncontrolled ascites, hepatic encephalopathy, Gilbert's syndrome, and sclerosing cholangitis, etc.;

    7. The participant was included in other clinical trials 30 days before the selection;

    8. Other conditions that the investigators considered that not unsuitable for inclusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Hospital Hefei Anhui China 230000
    2 Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430000
    3 West China Hospital Chengdu Sichuan China 610000
    4 180 Fenglin Road Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital
    • Tongji Hospital
    • Anhui Provincial Hospital
    • West China Hospital

    Investigators

    • Principal Investigator: Jian Zhou, Shanghai Zhongshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jian Zhou, Professor of Surgery, Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT04227808
    Other Study ID Numbers:
    • HCC-LEN-Adjuvant
    First Posted:
    Jan 14, 2020
    Last Update Posted:
    Jan 14, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Lenvatinib

    Study Results

    No Results Posted as of Jan 14, 2020