Proceedings of clinical trials on bile tract cancer

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.