研究单位：[1]Yiviva Inc.[2]Gastroenterology & Hepatology Clinic,Flushing,New York,United States,11355[3]Northwell Monter Cancer Institute,Lake Success,New York,United States,11042[4]Memorial Sloan Kettering Cancer Center,New York,New York,United States,10065[5]University Hospitals Cleveland Medical Center,Cleveland,Ohio,United States,44106[6]Beijing You'An Hospital, Capital Medical University,Beijing,Beijing,China[7]Cancer Hospital Chinese Academy of Medical Sciences,Beijing,Beijing,China[8]China-Japan Friendship Hospital,Beijing,Beijing,China[9]Foshan Hospital of Traditional Chinese Medicine,Foshan,Guangdong,China[10]Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,Guangdong,China[11]The First Affiliated Hospital, Sun Yat-Sen University,Guangzhou,Guangdong,China[12]Shenzhen People''s Hospital,Shenzhen,Guangdong,China[13]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China[14]Hunan Cancer Hospital,Changsha,Hunan,China[15]LongHua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai,Shanghai,China[16]Shanghai Eastern Hepatobiliary Hospital,Shanghai,Shanghai,China[17]Shanghai University of Traditional Chinese Medicine Shuguang Hospital,Shanghai,Shanghai,China[18]Queen Mary Hospital,Hongkong,Hong Kong[19]China Medical University Hospital,Taichung,Taiwan[20]National Cheng Kung University Hospital,Tainan,Taiwan[21]Cancer Research Center, Taipei Municipal Wanfang Hospital,Taipei,Taiwan[22]Taipei Medical University -Shuang Ho Hospital, Ministry of Health and Welfare,Taipei,Taiwan[23]Taipei Medical University Cancer Center,Taipei,Taiwan[24]Taipei Veterans General Hospital,Taipei,Taiwan[25]Chang Gung Memorial Hospital, Linkou,Taoyuan,Taiwan
The aim of this study is to compare the efficacy and safety of YIV-906 plus standard-of-care sorafenib versus those of sorafenib alone as a first-line systemic treatment for patients with Hepatitis B (+) associated advanced hepatocellular carcinoma. YIV-906 (PHY906, KD018) is an immune system modulator. Clinical and preclinical research suggests that YIV-906 could act to enhance the body's immune response to fight cancer and increase the anti-tumor activity of sorafenib and protect and repair the gastrointestinal tract by reducing inflammation and promoting tissue regeneration. Inspired by a 1,800-year-old traditional medicine still in use today, YIV-906 is a botanical drug candidate, composed of an extract of four herbs and administered in oral capsule form. The CALM (Combination of YIV-906 and Sorafenib to treat Advanced Liver cancer in a Multi-center study) trial is a multi-regional, randomized, placebo-controlled study.
