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

NCT04227808 | Unknown Phase 2

• 1 other identifier: HCC-LEN-Adjuvant
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year after LPI

Secondary Outcomes (4)

• Overall survival (OS)

  3 years

• Adverse events

  13 months

• Serious adverse events(SAE)

  13 months

• Health-related quality of life

  13 months

Study Arms (1)

Lenvatinib Arm

EXPERIMENTAL

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

Interventions

Lenvima 4 mg Oral Capsule DRUG

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.

Also known as: Lenvatinib 4 mg Oral Capsule

Lenvatinib Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Tongji Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• West China Hospital: collaborator

Study Sites (4)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 29433850 BACKGROUND

• 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.

  PMID: 30319983 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian Zhou

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou

CONTACT

0086-21-64041990; zhou.jian@zs-hospital.sh.cn

Huichuan Sun

CONTACT

0086-21-64041990; sun.huichuan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 14, 2020
• Study Start: December 12, 2019
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2022
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)