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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Shanghai、中国、200040
- Huashan Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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
他の名前：
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アクティブコンパレータ：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
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease free survival
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全生存
時間枠：5年
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肝切除後の生存期間
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5年
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lunxiu Qin, MD、Department of general surgery, Huashan hospital, Fudan University
出版物と役立つリンク
一般刊行物
- 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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研究開始 (実際)
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研究の完了 (予想される)
試験登録日
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最終確認日
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