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Brief Title: YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)
Official Title: A Phase II Randomized Placebo-Controlled Study Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma
Study ID: NCT04000737
Brief Summary: 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.
Detailed Description: HCC patients with chronic HBV (+) (HBsAg(+)), and Child-Pugh A status will be randomized to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib) at ratio of 2:1. Patients will be stratified according to metastatic status (extrahepatic/vascular invasion vs. none), and their ECOG performance status (0 vs. 1) at randomization. * ARM I: Patients receive Placebo + Sorafenib * ARM II: Patients receive YIV-906+ Sorafenib Patients in the study arm will be treated orally each 28-day course with YIV-906 (600 mg (3 capsules) BID) + sorafenib (400 mg BID) according to the following schedule: sorafenib BID daily treatment for 28 days, and YIV-906 BID 4 days on and 3 days off weekly in each course. All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 5.0 (CTCAE). The Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be used to establish disease response or progression. The RECIST 1.1 and mRECIST will be used in a blinded independent central review (BICR) to determine the study endpoints. Patients will be evaluated for PFS, TTP, OS, antitumor response every two cycles, and QoL and safety at the beginning of each cycle. Biomarkers are mandatory and will be studied prior to drug administration on day 1 of each cycle. TCM Syndrome Research is optional. PK is only applicable in China study sites and limited to the first 15 male and 15 female patients. Patients will be randomized to either the study drug arm or the placebo arm (2:1 ratio). PK studied immediately prior to dose administration and at 1 hour, 2 hours, 4 hours, and 12 hours post-dose administration on Day 1 of Cycles 1.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Calvin Pan. MD Gastroenterology & Hepatology Clinic, Flushing, New York, United States
Northwell Monter Cancer Institute, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Beijing You'An Hospital, Capital Medical University, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
China-Japan Friendship Hospital, Beijing, Beijing, China
Foshan Hospital of Traditional Chinese Medicine, Foshan, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Shenzhen People's Hospital, Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Hunan Cancer Hospital, Changsha, Hunan, China
LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China
Shanghai Eastern Hepatobiliary Hospital, Shanghai, Shanghai, China
Shanghai University of Traditional Chinese Medicine Shuguang Hospital, Shanghai, Shanghai, China
Queen Mary Hospital, Hongkong, , Hong Kong
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Cancer Research Center, Taipei Municipal Wanfang Hospital, Taipei, , Taiwan
Taipei Medical University -Shuang Ho Hospital, Ministry of Health and Welfare, Taipei, , Taiwan
Taipei Medical University Cancer Center, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan, , Taiwan
Name: Yun Yen, MD/PhD
Affiliation: Taipei Medical University
Role: STUDY_CHAIR
Name: Ghassan Abou-Alfa, MD/MBA
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR