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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lenvatinib

TACE

External beam radiation (RT)

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RT+TACE+Lenvatinib

TACE+Lenvatinib

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall Survival (OS)

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

Secondary Outcome Measures

Progression-Free Survival (PFS)

PFS is defined as the time from the first day of lenvatinib oral administration to progression or death.

Objective Response Rate (ORR)

ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Disease Control Rate (DCR)

DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria.

ncidence of Adverse Events (AE)

The percentage of patients who suffer adverse events from the first day of lenvatinib oral administration to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Full Information

NCT ID

NCT05592197

First Posted

October 20, 2022

Last Updated

February 14, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05592197

Brief Title

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

Official Title

Safety and Efficacy of External Beam Radiation Plus Transarterial Chemoembolization and Lenvatinib vs Transarterial Chemoembolization and Lenvatinib in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Withdrawn

Why Stopped

This is a sub-study of another one.

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RT+TACE+Lenvatinib

Arm Type

Experimental

Arm Description

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.

Arm Title

TACE+Lenvatinib

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

External beam radiation (RT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

PFS is defined as the time from the first day of lenvatinib oral administration to progression or death.

Time Frame

Up to 2 years

Title

Objective Response Rate (ORR)

Description

Time Frame

Up to 2 years

Title

Disease Control Rate (DCR)

Description

DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria.

Time Frame

Up to 2 years

Title

ncidence of Adverse Events (AE)

Description

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Kuang, Ph.D.

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35921605

Citation

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.

Results Reference

background

PubMed Identifier

34899910

Citation

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.

Results Reference

background

PubMed Identifier

29543938

Citation

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.

Results Reference

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

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