Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma
A Prospective Cohort Study of the Effect of Lenvatinib Combined With TACE in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Postoperative recurrence and metastasis of hepatocellular carcinoma(HCC）is the main problem during the treatment. Although with the development of medical science, some drugs have been found for the prevention and treatment of postoperative recurrence of HCC (such as postoperative application of interferon to prevent early tumor recurrence), but there is still no drug widely recognized.
Transcatheter arterial chemoembolization (TACE) is a palliative treatment for hepatocellular carcinoma. TACE can detect the early recurrence of tumor after liver resection, and has a complementary treatment effect on hidden residual lesions. For patients with high-risk, the tumor recurrence rate can be significantly reduced, and the tumor-free survival can be prolonged by TACE. Therefore, patients with high-risk of recurrence after resection were routinely arranged TACE treatment as an adjuvant treatment after surgery.
Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT, thereby inhibiting tumor cell proliferation, inducing apoptosis, and acting as an anti-angiogenesis. The REFLECT study showed that the median overall survival(OS) of the patients in the lenvatinib group was 13.6 months (95% CI, 12.1-14.9) and that in the sorafenib group was 12.3 months (95% CI, 10.4-13.9) , which reached a non-inferiority end point (HR = 0.92; 95% CI, 0.79-1.06). In addition, all secondary endpoints in the lenvatinib group were significantly better than the sorafenib group. A subgroup analysis based on Chinese patients showed that the OS of Lenvatinib was significantly 4.8 months longer than sorafenib group (15.0 months vs 10.2 months). Other three secondary endpoints, progression-free survival(PFS) (9.2 months vs 3.6) and time to progression(TTP)(11.0 months vs 3.7 months) and objective response rate(ORR) (21.5% vs 8.3%), were also significantly better in Lenvatinib group. Based on the above datas, lenvatinib will become a new choice for Chinese patients with HCC. It has also been approved by the FDA and CFDA as the first-line treatment for patients with advanced HCC.
So, this study is to observe the effect of lenvatinib combined with TACE in preventing the recurrence in high-risk patients with HCC.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Shanghai, Cina, 200040
- Huashan Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- The characteristics of the treatment history:
No lenvatinib treatment history, no sorafenib allergies.
- The characteristics of the tumor:
The pathological results is hepatocellular carcinoma.
Meet any of the following articles:
Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number≥3,Tumor size≥8cm,Tumor margin is not clear and no complete capsule.
With the embolus in Portal vein, hepatic vein or bile duct. Preoperative rupture or invasion the adjacent organs.
- The characteristics of the patients:
The patient age was between 18-75. The American Society of Anesthesiologists(ASA）score was I-III. The Child-pugh score was A. Total bilirubin≤3.0 mg/dL, albumin≥28 g/L, AST, ALT, ALP≤5 times the upper limit of normal value.
Routine blood test: the neutrophil≥1.5×10^9/L, Hb≥8.5g/L，PLT≥75×10^9/L. The INR≤2.3. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points
Exclusion Criteria:
- R1/2 or palliative rescted tumor
- Pregnant or lactating women.
- Patients with other malignant tumor.
- Patients with mental illness.
- Patients participated in other clinical trials in last three months.
- Residual lesions showed by Postoperative digital subtraction angiography(DSA).
- Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: lenvatinib
use lenvatinib after liver resection in HCC patients
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for patients <60kg, lenvatinib 8mg bid po for patients >60kg, lenvatinib 12mg bid po
Altri nomi:
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Comparatore attivo: lenvatinib and TACE
use lenvatinib and TACE after liver resection in HCC patients
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for patients <60kg, lenvatinib 8mg bid po for patients >60kg, lenvatinib 12mg bid po
Altri nomi:
The patient underwent transfemoral hepatic artery angiography one month after surgery to observe whether there was tumor staining in the liver.
If there was suspicious tumor staining, micro-catheter was superselected to the tumor blood vessel, the embolization agents and chemotherapy drugs were injected.
If there was no tumor staining, a small amount of embolization agents were slowly injected into the artery.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Disease free survival
Lasso di tempo: 2 years
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the survival time after liver resection without tumor recurrence or metastasis
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2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sopravvivenza globale
Lasso di tempo: 5 anni
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il tempo di sopravvivenza dopo resezione epatica
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5 anni
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lunxiu Qin, MD, Department of general surgery, Huashan hospital, Fudan University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
- Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24.
- Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Attributi della malattia
- Neoplasie dell'apparato digerente
- Malattie del fegato
- Neoplasie del fegato
- Carcinoma
- Carcinoma, epatocellulare
- Ricorrenza
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Lenvatinib
Altri numeri di identificazione dello studio
- Huashan 004
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