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This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT+TACE+Lenvatinib | Experimental | Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE. |
|
| Lenvatinib | Active Comparator | Patients in Lenvatinib group will take oral lenvatinib alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients ≥ 60kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from first treatment to death, regardless of disease recurrence. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the first treatment to progression or death. | Up to 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Kuang, Ph.D. | Contact | 008687755766 | 8576 | kuangm@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Kuang, Ph.D. | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35921605 | Background | 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. | |
| 34899910 |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| 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. |
|
| SBRT | Radiation | SBRT will be given within 3 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 4500-5000 cGy in 5-8 fractions. |
|
| Up to 2 years |
| 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 |
| Incidence of Adverse Events (AE) | Incidence of AE is defined as the percentage of patients who suffer adverse events from the first treatment to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Up to 2 years |
| Time to Progression (TTP) | TTP is defined as the time from the first treatment to progression. | Up to 2 years |
| 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. |
| 29543938 | 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. |