Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation

NCT04415567 | Completed FDA Drug

• 1 other identifier: XH-20-010
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is no study on its effect in preventing HCC recurrence in the patients undergoing transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9) with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were evaluated.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; liver transplantation; lenvatinib; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  The disease-free survival (DFS) was defined as the period between the day of LT and the day of HCC recurrence confirmed by imaging.

  up to 3 years

Secondary Outcomes (1)

• Overall survival (OS)

  up to 3 years

Other Outcomes (1)

• 3-year Recurrence rate (RR)

  3 years

Study Arms (2)

lenvatinib

high-risk patients with HBV-related HCC who took lenvatinib as adjuvant therapy after liver transplantation

Drug: Lenvatinib

control

high-risk patients with HBV-related HCC who received routine treatment and follow-up after liver transplantation

Interventions

Lenvatinib DRUG

The patients in lenvatinib group received oral lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW \<60 kg) in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8 mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for more than 3 cycles.

lenvatinib

Eligibility Criteria

• Age: 8 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohorts in the study involved the patients who underwent liver transplantation for HBV-related HCC and were diagnosed as "high-risk" for recurrence according the above criteria.

You may qualify if:

• The recipients who underwent liver transplantation with the pathologic diagnosis of hepatocellular carcinoma.
• The extrahepatic metastasis was excluded preoperatively.
• The patients were defined as "high-risk" for recurrence according to the following criteria:
• (1) beyond Milan criteria confirmed either by radiology before LT or by pathology after LT, (2) tumor with intrahepatic vascular invasion, (3) Alpha-fetoprotein (AFP)≥400ng/L before LT, (4) presence of microvascular invasion (MVI), (5) tumor with histological poor differentiation according to Edmondson-Steiner classification system(21), (6) multiple satellite lesions around the largest tumors detected either by radiology before LT or by histology after LT, (7) tumor penetrating hepatic capsule, (8) recurrent HCC after resection. 4. ECOG score between 0-1 within 1 week before took lenvatinib. 5. The patients have received regular antiviral treatment. 6. Life expectancy more than 3 months.

You may not qualify if:

• The patients took lenvatinib before liver transplantation and assessed as SD or PD according to the mRECIST criteria.
• The patients suffered from other incurable malignancies within 5 years or at the same time.
• Distant metastasis of tumor was confirmed by imaging before or within 1 month after transplantation.
• The patients have not received regular antiviral treatment.
• The patients had a history of mental illness or abuse of psychoactive drugs.
• The patients deemed unsuitable by attending doctors.

Sponsors & Collaborators

• Jinyang Gu: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School

Shanghai, 200092, China

Location

Related Publications (4)

• 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 RESULT

• Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.

  PMID: 32265508 RESULT

• Siegel AB, El-Khoueiry AB, Finn RS, Guthrie KA, Goyal A, Venook AP, Blanke CD, Verna EC, Dove L, Emond J, Kato T, Samstein B, Busuttil R, Remotti H, Coffey A, Brown RS Jr. Phase I trial of sorafenib following liver transplantation in patients with high-risk hepatocellular carcinoma. Liver Cancer. 2015 Mar;4(2):115-25. doi: 10.1159/000367734.

  PMID: 26020033 RESULT

• Teng CL, Hwang WL, Chen YJ, Chang KH, Cheng SB. Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study. World J Surg Oncol. 2012 Feb 17;10:41. doi: 10.1186/1477-7819-10-41.

  PMID: 22339891 RESULT

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

• Jinyang Gu, PhD

  Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available from the manuscript accepted by a journal to five years after that.
• Access Criteria: The data will become available when the manuscript accepted by a journal, until five years after that.

Locations

CN (1)