search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lenvima 4 mg Oral Capsule
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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<4.0*10^9/L, HB<80 g/L, and PLT<75*10^9/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.

Sites / Locations

  • Anhui Provincial HospitalRecruiting
  • Tongji Hospital, Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • West China HospitalRecruiting
  • 180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenvatinib Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

1-year RFS rate
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

Overall survival (OS)
The duration from the date of first dosage to the date of death from any cause.
Adverse events
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.
Serious adverse events(SAE)
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.
Health-related quality of life
Health-related quality of life questionnaire measured by EORTC QLQ-HCC18.

Full Information

First Posted
January 5, 2020
Last Updated
January 11, 2020
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Tongji Hospital, Anhui Provincial Hospital, West China Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04227808
Brief Title
Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Tongji Hospital, Anhui Provincial Hospital, West China Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lenvima 4 mg Oral Capsule
Other Intervention Name(s)
Lenvatinib 4 mg Oral Capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year RFS rate
Description
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.
Time Frame
1 year after LPI
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The duration from the date of first dosage to the date of death from any cause.
Time Frame
3 years
Title
Adverse events
Description
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.
Time Frame
13 months
Title
Serious adverse events(SAE)
Description
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.
Time Frame
13 months
Title
Health-related quality of life
Description
Health-related quality of life questionnaire measured by EORTC QLQ-HCC18.
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged 18-75; Histological diagnosis of HCC; 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); 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; Adequate liver, renal functions; Written informed consent; ECOG 0-1 and Child-Pugh A. Exclusion Criteria: WBC<4.0*10^9/L, HB<80 g/L, and PLT<75*10^9/L at blood screening; Coagulation function: (prothrombin time) international normalized ratio (INR) >2.3, or extension of prothrombin time>6 seconds; 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; Renal function: serum creatinine (Cr)>1.5 times the upper limit of normal range; lymph node metastases; The participant has uncontrolled ascites, hepatic encephalopathy, Gilbert's syndrome, and sclerosing cholangitis, etc.; The participant was included in other clinical trials 30 days before the selection; Other conditions that the investigators considered that not unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhou
Phone
0086-21-64041990
Email
zhou.jian@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huichuan Sun
Phone
0086-21-64041990
Email
sun.huichuan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhou
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianxin Liu
First Name & Middle Initial & Last Name & Degree
Weidong Jia
Facility Name
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Huang
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianfu Wen
Facility Name
180 Fenglin Road
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhou
Phone
0086-21-64041990
Email
zhou.jian@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Huichuan Sun
Phone
0086-21-64041990
Email
sun.huichuan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Jian Zhou
First Name & Middle Initial & Last Name & Degree
Huichuan Sun

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29433850
Citation
Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
Results Reference
background
PubMed Identifier
30319983
Citation
Zhou J, Sun HC, Wang Z, Cong WM, Wang JH, Zeng MS, Yang JM, Bie P, Liu LX, Wen TF, Han GH, Wang MQ, Liu RB, Lu LG, Ren ZG, Chen MS, Zeng ZC, Liang P, Liang CH, Chen M, Yan FH, Wang WP, Ji Y, Cheng WW, Dai CL, Jia WD, Li YM, Li YX, Liang J, Liu TS, Lv GY, Mao YL, Ren WX, Shi HC, Wang WT, Wang XY, Xing BC, Xu JM, Yang JY, Yang YF, Ye SL, Yin ZY, Zhang BH, Zhang SJ, Zhou WP, Zhu JY, Liu R, Shi YH, Xiao YS, Dai Z, Teng GJ, Cai JQ, Wang WL, Dong JH, Li Q, Shen F, Qin SK, Fan J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition). Liver Cancer. 2018 Sep;7(3):235-260. doi: 10.1159/000488035. Epub 2018 Jun 14.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs