Clinical trial NCT05592197: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: ncidence of Adverse Events (AE)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, Ph.D.
role: STUDY_CHAIR
References:
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.
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.
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.