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

Advanced Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05592197
• Other study ID #: HCC202211
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 2023

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Procedure:
• TACE
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.

Radiation:
• External beam radiation (RT)
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-Free Survival (PFS)	PFS is defined as the time from the first day of lenvatinib oral administration to progression or death.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	Up to 2 years