胆道恶性肿瘤临床研究进展
收稿日期: 2023-03-07
网络出版日期: 2025-01-23
基金资助
国家自然科学基金项目(82172628);国家自然科学基金项目(82473043)
Proceedings of clinical trials on bile tract cancer
Received date: 2023-03-07
Online published: 2025-01-23
胆道恶性肿瘤（bile tract cancer, BTC）侵袭性强，早期诊断困难。尽管根治性手术是目前BTC的主要治愈性措施，但多数BTC病人就诊时已经处于疾病进展期或晚期。即使接受根治性手术切除，术后肿瘤复发风险也居高不下，5年生存率低。多项关于BTC大规模多中心前瞻性临床研究结果公布，对于优化BTC的治疗方案具有里程碑意义。BILCAP、ASCOT研究肯定辅助化疗在可切除BTC的重要地位。伊立替康作为进展期BTC病人的二线化疗药物也有近期的研究数据证实。TOPAZ-1研究首次宣告一线免疫疗法联合化疗的优效性。在靶向治疗方面，泽尼达妥单抗、T-DXd、奈拉替尼等靶向HER2的药物开发取得突破。 SAGC、SPINE研究显示免疫治疗联合化疗或其他靶向治疗药物生存获益可能更好。基于这些临床研究数据，国内、外相应指南也进行了更新。伴随着现阶段肿瘤分子诊断技术的飞速发展，BTC基因表达信息的深入挖掘，BTC精准医疗研究步入新的时代，期待后续更多的临床研究及真实世界数据分析、更多临床实践应用经验的积累，为BTC病人提供更优的治疗选择。
熊逸晨 , 杨自逸 综述 , 桑玉尔 , 龚伟 审校 . 胆道恶性肿瘤临床研究进展[J]. 外科理论与实践, 2024 , 29(05) : 455 -460 . DOI: 10.16139/j.1007-9610.2024.05.15
Bile tract cancer (BTC) is aggressive and difficult to diagnose at an early stage. So far, radical surgery is the main curative measure for BTC, most patients with BTC are already in progressive or advanced stage at the time of diagnosis. Even after radical surgical resection, the risk of tumor recurrence remains high, and the 5-year survival rate is low. The results of several large-scale multicenter prospective clinical trials about BTC were published. All of these are significant for optimizing therapeutic strategies for BTC. BILCAP and ASCOT studies confirm the vital role of adjuvant chemotherapy in resectable BTC. Irinotecan as a second-line chemotherapy agent for patients with advanced BTC has also been confirmed by recent research data. TOPAZ-1 study was the first to demonstrate the superior efficacy of first-line immunotherapy combined with chemotherapy. In terms of targeted therapy, breakthroughs have been made in the development of HER2-targeting drugs such as zanidatamab, T-DXd, and neratinib. SAGC and SPINE studies showed that immunotherapy combined with chemotherapy or other targeted therapeutics may yield better survival benefit. Based on the data from these clinical studies, the corresponding guidelines have been updated both domestically and internationally. Along with the advances of tumor molecular diagnostic technology and the in-depth mining of gene expression information of BTC, BTC precision medical research has entered a new era. We expect more clinical studies and real-world data analysises and more clinical practice application experiences to provide better treatment options for BTC patients.
Key words： Bile tract cancer(BTC); Clinical trial; Precision medicine
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