Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT

NCT05592197 | Withdrawn DMC

• 1 other identifier: HCC202211
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from the first day of lenvatinib oral administration to death, regardless of disease recurrence.

  Up to 2 years

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• ncidence of Adverse Events (AE)

  Up to 2 years

Study Arms (2)

RT+TACE+Lenvatinib

EXPERIMENTAL

Patients in RT+TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib. RT will begin within 4 weeks after the first TACE.

Drug: Lenvatinib; Procedure: TACE; Radiation: External beam radiation (RT)

TACE+Lenvatinib

ACTIVE COMPARATOR

Patients in TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib.

Drug: Lenvatinib; Procedure: TACE

Interventions

Lenvatinib DRUG

Lenvatinib will be initially provided to patients first (dose: 8 mg qd for patients \< 60 kg, and 12 mg qd for patients ≥ 60 kg)

RT+TACE+Lenvatinib; TACE+Lenvatinib

TACE PROCEDURE

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.

RT+TACE+Lenvatinib; TACE+Lenvatinib

External beam radiation (RT) RADIATION

RT will be given within 4 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 4500-6000 cGy in 25 fractions.

RT+TACE+Lenvatinib

Eligibility Criteria

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

You may qualify if:

• age 18-75 years;
• histologically or cytologically or clinically confirmed diagnosis of HCC;
• presenting with PVTT and at least one measurable intrahepatic lesion on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); an intrahepatic lesion consisting of a single tumor (≤ 10.0 cm) or multiple tumors (≤ 3 foci) with the tumor burden \< 50%;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Child-Pugh class A or B;
• life expectancy of at least 3 months;
• satisfactory blood, liver, and kidney function parameters. The acceptable blood, liver, and kidney parameters were (1) neutrophil count ≥ 1.5 × 109/L; (2) platelet count ≥ 60 × 109/L; (3) hemoglobin concentration ≥ 90 g/L; (4) serum albumin concentration ≥ 30 g/L; (5) bilirubin ≤ 50 μmol/L; (6) AST and ALT \< 5 × upper limit of normal (ULN) and alkaline phosphatase \< 4 × ULN; (7) extended prothrombin time \< 6 seconds of ULN; and (8) serum creatinine \< 1.5 × ULN.

You may not qualify if:

• history of liver and adjacent tissue radiation;
• medical history of hepatic decompensation, such as hepatic encephalopathy and esophageal or gastric variceal bleeding;
• extrahepatic spread;
• combination with other malignant diseases;
• contraindications for TACE;
• pregnant and lactating women;
• severe dysfunction of the heart, kidney, or other organs;
• hypersensitivity to intravenous contrast agents;
• with HIV, syphilis infection;
• allogeneic organ transplant recipients;
• suffering from mental and psychological diseases may affect informed consent;
• unable to take oral medication;
• active gastric or duodenal ulcers within 3 months before enrollment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

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: 35921605 BACKGROUND

• 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: 34899910 BACKGROUND

• 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: 29543938 BACKGROUND

MeSH Terms

Interventions

lenvatinib

Study Officials

• Ming Kuang, Ph.D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: October 20, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)