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This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib + TACE | Experimental | Patients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. |
|
| Lenvatinib | Active Comparator | Lenvatinib alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | TACE will be performed one day after oral administration of lenvatinib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of each center. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from randomization to death for any cause. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Defined as the time from randomization to disease progression. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Kuang, PhD | Contact | 008687755766 | kuangm@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Kuang, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29433850 | Background | Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1. | |
| 29307467 |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| 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) |
|
| Background |
| Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5. |
| 28648803 | Background | Meyer T, Fox R, Ma YT, Ross PJ, James MW, Sturgess R, Stubbs C, Stocken DD, Wall L, Watkinson A, Hacking N, Evans TRJ, Collins P, Hubner RA, Cunningham D, Primrose JN, Johnson PJ, Palmer DH. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):565-575. doi: 10.1016/S2468-1253(17)30156-5. Epub 2017 Jun 23. |
| 30529387 | Background | Park JW, Kim YJ, Kim DY, Bae SH, Paik SW, Lee YJ, Kim HY, Lee HC, Han SY, Cheong JY, Kwon OS, Yeon JE, Kim BH, Hwang J. Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. J Hepatol. 2019 Apr;70(4):684-691. doi: 10.1016/j.jhep.2018.11.029. Epub 2018 Dec 6. |
| 35921605 | Derived | 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. |