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

Not Applicable

Withdrawn

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib; Procedure: TACE; Radiation: External beam radiation (RT)

• Registration Number: NCT05592197
• Lead Sponsor: Sun Yat-sen University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. age 18-75 years;
2. histologically or cytologically or clinically confirmed diagnosis of HCC;
3. 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%;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Child-Pugh class A or B;
6. life expectancy of at least 3 months;
7. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT+TACE+Lenvatinib	TACE	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.
TACE+Lenvatinib	TACE	Patients in TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib.
RT+TACE+Lenvatinib	External beam radiation (RT)	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.
RT+TACE+Lenvatinib	Lenvatinib	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.
TACE+Lenvatinib	Lenvatinib	Patients in TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 2 years	OS is defined as the time from the first day of lenvatinib oral administration to death, regardless of disease recurrence.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 2 years	PFS is defined as the time from the first day of lenvatinib oral administration to progression or death.
Disease Control Rate (DCR)	Up to 2 years	DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria.
Objective Response Rate (ORR)	Up to 2 years	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.
ncidence of Adverse Events (AE)	Up to 2 years	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China