Journal of Surgery Concepts & Practice ›› 2025, Vol. 30 ›› Issue (2): 93-100.doi: 10.16139/j.1007-9610.2025.02.01
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LI Chun, MA Zuyi, SUN Jia, LI Binglu()
Received:
2025-02-16
Online:
2025-03-25
Published:
2025-07-07
Contact:
LI Binglu
E-mail:PUMCHLBL@163.com
CLC Number:
LI Chun, MA Zuyi, SUN Jia, LI Binglu. Systemic therapy for advanced cholangiocarcinoma: divergences in global guidelines and regional clinical implementation[J]. Journal of Surgery Concepts & Practice, 2025, 30(2): 93-100.
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URL: https://www.qk.sjtu.edu.cn/jscp/EN/10.16139/j.1007-9610.2025.02.01
Tab 1
Evidence-based summary of partial chemotherapy regimens for advanced CCA
化疗方案 | 研究编号 | 研究阶段 | 研究人群来源 | 对比方案 | 纳入病人数量 | 主要终点 | 关键结果 |
---|---|---|---|---|---|---|---|
GemCis | NCT00262769 | Ⅲ期(ABC-02) | 英国 | GemCis 比 吉西他滨 | 410 | OS | 11.7个月比8.1个月 (HR=0.64, P<0.001) |
吉西他滨+替吉奥 | UMIN000010667 | Ⅲ期 (JCOG1113) | 日本 | 吉西他滨+替吉奥 比 吉西他滨 | 354 | OS,非劣效性 | 15.1个月比13.4个月 (HR=0.945, P=0.0459) |
GemCis+替吉奥 | NCT02182778 | Ⅲ期 (KHBO1401- MITSUBA) | 日本 | GemCis+替吉奥比 GemCis | 246 | OS | 13.5个月比12.6个月 (HR=0.79, P=0.046) |
XELOX | NCT01470443 | Ⅲ期 | 韩国 | 卡培他滨+奥沙利铂 比 吉西他滨+奥沙利铂 | 224 | PFS率(6个月),非劣效性 | 46.7%比44.6%,符合非劣效标准 |
Tab 2
NCCN guidelines for molecular targeted therapy recommendations
分子特征 | 药物 | 治疗阶段 | 研究阶段 | 文献来源 |
---|---|---|---|---|
FGFR2融合 | 福巴替尼(futibatinib) | 二线治疗 | Ⅱ期 (FIGHT-202、FOENIX-CCA2) | Vogel A 2024;Abou-Alfa GK 2020 |
培米替尼(pemigatinib) | ||||
HER2阳性 | 德曲妥珠单抗(fam-trastuzumab deruxtecan-nxki) | 二线治疗 | Ⅱ期 | Meric-Bernstam F 2024;Javle M 2021;Nakamura Y 2023 |
曲妥珠单抗+帕妥珠单抗(trastuzumab + pertuzumab) | ||||
妥卡替尼 + 曲妥珠单抗(tucatinib + trastuzumab) | ||||
IDH1突变 | 艾伏尼布(ivosidenib)(1类) | 二线治疗 | Ⅲ期 (ClarIDHy) | Ghassan K Abou-Alfa 2020 |
NTRK基因融合阳性 | 恩曲替尼(entrectinib) | 一线治疗、 二线治疗 | 多瘤种Ⅱ期 (basket) | Doebele RC 2020; Solomon BJ 2023 |
拉罗替尼(larotrectinib) | ||||
瑞普替尼(repotrectinib) | ||||
BRAF V600E突变 | 达拉非尼 + 曲美替尼(dabrafenib + trametinib) | 二线治疗 | Ⅱ期 (ROAR) | Subbiah V 2020 |
RET基因融合阳性 | 普拉替尼(pralsetinib)(2B类) | 一线治疗、 二线治疗 | Ⅰ/Ⅱ期 | Subbiah V 2022 |
塞尔帕替尼(selpercatinib)(2B类) | ||||
KRAS G12C突变阳性 | 阿达格拉西布(adagrasib) | 二线治疗 | Ⅱ期 | Tanios S 2023 |
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