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TOPAZ-1 study
background
BTC accounts for 3% of all gastrointestinal malignancies and has 200,000method
In this study, previously unresectable locally advanced, recurrent, or metastatic BTC patients were randomized in a 1:1 ratio receiving varyuliumab (1500 mg every 3 weeks [Q3W]) or placebo, respectively, for 8 cycles with GemCis (Gem days 1 and 8 1000 mg/m2 and Cis 25 mg/m2, Q3W) for 8 cycles, followed by valliyumab (1500 mg every 4 weeks [Q4W]).outcome
In the interim analysis presented at this year's ASCO conference (data deadline August 11, 2021), 685 patients were randomly assigned 1:1 to dovalidomab plus GemCis (n=341) or placebo + GemCis (n=344), with baseline features balancedconclusion
Dovalizumab combined with GemCis regimen chemotherapy can provide OS benefit compared with gemCis regimen chemotherapy alone, with a 2-year survival rate of 24.Founder of i Hope Medicine
Professor Qin Haifeng
Shanxi i Hope College
Professor Zhao Jun
Professor Zhao Jun, Dean of Shanxi i Hope College, invited Professor Liu Xiaoling of Shanxi Cancer Hospital to interpret the study and share the analysis and thinking of immunotherapy related to biliary tumors
Review experts
Professor Liu Xiaoling
Chief Physician, Master of Medicine
Shanxi Province's 100 million high-end leading talents in the health talent training project
He specializes in the diagnosis, chemotherapy and comprehensive treatment of gastrointestinal tumors such as esophageal cancer, gastric cancer, colorectal cancer, liver cancer and pancreatic cancer
Vice Chairman of the Youth Committee of the Tumor Chemotherapy Professional Committee of Shanxi Anti-Cancer Association
Vice Chairman of the Neuroendocrine Tumor Professional Committee of Shanxi Anti-Cancer Association
Member of the Academic Steering Committee of the Rehabilitation Society of the Chinese Anti-Cancer Association
Member of the Pelvic Tumor Professional Committee of the Chinese Medical Education Association
Member of the Standing Committee of the Clinical Oncology Professional Committee of Shanxi Women Physicians Association
Member of the Colorectal Cancer Professional Committee of Shanxi Anti-Cancer Association
Expert of Shanxi Provincial Health Education Expert Committee
Professor Liu Xiaoling: At present, the treatment of malignant tumors has entered the era of immunotherapy, and the immune checkpoint inhibitors represented by PD-1/PD-L1 monoclonal antibody have been widely used in the treatment of multiple cancers in the clinic, and have achieved very good efficacy
The TOPAZ-1 study is the world's first phase III study in which the first line of immune combination chemotherapy obtained positive results for advanced BTC, and explored the efficacy and safety
Immunocomposent chemotherapy has become a new choice for the first-line treatment of advanced BTC, and it is necessary to explore how to further improve the efficacy and how to enrich the dominant population through molecular marker screening in the
References
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Li Jingjing et al.
A phase 2, randomized, open-label, multicenter study of sintilimab and anlotinib in combination with gemcitabine plus cisplatin (GemCis) as first-line therapy in patients ( pts) with advanced biliary tract cancer (BTC): SAGC.
2022 ASCO Abstract 4100
Review: Xiaoyuan
Layout: Xiaoyuan
Execution: Xiaoyuan
