NCT05718232

Brief Summary

This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
9mo left

Started Mar 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2023Feb 2027

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.9 years

First QC Date

January 29, 2023

Last Update Submit

February 7, 2023

Conditions

Advanced Hepatocellular Carcinoma

Keywords

SBRTTACELenvatinib

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS is defined as the time from first treatment to death, regardless of disease recurrence.

    Up to 2 years

Secondary Outcomes (5)

  • Progression-Free Survival (PFS)

    Up to 2 years

  • Objective Response Rate (ORR)

    Up to 2 years

  • Disease Control Rate (DCR)

    Up to 2 years

  • Incidence of Adverse Events (AE)

    Up to 2 years

  • Time to Progression （TTP）

    Up to 2 years

Study Arms (2)

SBRT+TACE+Lenvatinib

EXPERIMENTAL

Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE.

Drug: LenvatinibProcedure: TACERadiation: SBRT

Lenvatinib

ACTIVE COMPARATOR

Patients in Lenvatinib group will take oral lenvatinib alone.

Drug: Lenvatinib

Interventions

LenvatinibDRUG

Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients \<60kg, and 12 mg qd for patients ≥ 60kg)

LenvatinibSBRT+TACE+Lenvatinib
TACEPROCEDURE

TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center.

SBRT+TACE+Lenvatinib
SBRTRADIATION

SBRT will be given within 3 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-5000 cGy in 5-8 fractions.

SBRT+TACE+Lenvatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years old;
  • Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
  • There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus;
  • ECOG score 0-1;
  • Child-Pugh class A;
  • Expected survival time ≥ 3 months;
  • Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal.

You may not qualify if:

  • Extrahepatic metastases;
  • Previous history of liver or adjacent tissue radiation;
  • Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
  • There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
  • Hypersensitivity to intravenous contrast agents;
  • Pregnant or lactating women or subjects with family planning within two years;
  • With HIV, syphilis infection;
  • Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
  • Allogeneic organ transplant recipients;
  • Severe dysfunction of heart and kidney or other organs;
  • Active severe infection \> grade 2 (NCI-CTC version 5);
  • Suffering from mental and psychological diseases may affect informed consent;
  • Unable to take oral medication;
  • Participated in other drug clinical trials within 12 months before enrollment;
  • Active gastric or duodenal ulcers within 3 months before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (3)

  • Peng Z, Fan W, Zhu B, Wang G, Sun J, Xiao C, Huang F, Tang R, Cheng Y, Huang Z, Liang Y, Fan H, Qiao L, Li F, Zhuang W, Peng B, Wang J, Li J, Kuang M. Lenvatinib Combined With Transarterial Chemoembolization as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Phase III, Randomized Clinical Trial (LAUNCH). J Clin Oncol. 2023 Jan 1;41(1):117-127. doi: 10.1200/JCO.22.00392. Epub 2022 Aug 3.

    PMID: 35921605BACKGROUND

  • Abulimiti M, Li Z, Wang H, Apiziaji P, Abulimiti Y, Tan Y. Combination Intensity-Modulated Radiotherapy and Sorafenib Improves Outcomes in Hepatocellular Carcinoma with Portal Vein Tumor Thrombosis. J Oncol. 2021 Dec 3;2021:9943683. doi: 10.1155/2021/9943683. eCollection 2021.

    PMID: 34899910BACKGROUND

  • Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.

    PMID: 29543938BACKGROUND

MeSH Terms

Interventions

lenvatinib

Study Officials

  • Ming Kuang, Ph.D.

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Ming Kuang, Ph.D.

CONTACT

008687755766kuangm@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)