Spots Global Cancer Trial Database for The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects
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Trial Identification
Brief Title: The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects
Official Title: Comparison of Efficacy and Safety of Icaritin Versus Sorafenib in First-line Treatment of PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects: a Multicenter, Randomized, Opened Phase III Clinical Trial
Study ID: NCT03236649
Conditions
Study Description
Brief Summary: The primary efficacy index of this study is to compare the OS of the two groups.
Detailed Description: Icaritin is a newly discovered small molecular compound which is high selective ERa36 modulators ,the preclinical PK\&PD and toxicity studies showed it can inhibit the growth of HCC cancer cells both in vitro and in vivo, combining clinical data perhaps it will be a very promising new drug to treat hepatocellular carcinoma (HCC) by targeting this nongenomic pathway. Shenogen decided to further investigate the efficacy and safety of Icaritin and to explore potential gene targets for treating HCC. The results of phase I study showed Icaritin has good safety and tolerance. The biological availability of Icaritin after meal is high and the half-life is relatively short. The phase Ib study enrolled 28 subjects. Among the 18 HCC subjects, 12 subjects received treatment in the oral administration group with 600 mg once, twice per day, after meal 30 minutes, 6 subjects received treatment in the oral administration group with 800 mg once, twice per day, after meal 30 minutes. The results showed that in the 600mg group there are 12 HCC patients whose therapeutic efficacy is evaluable now, one case of PR (10%), 5 cases of SD (50%) and 4 cases of PD (40%) were observed.Safety data showed that totally 24 AEs are probably related to investigational drug. Among them, 19 AEs are grade I, 5 AEs are grade II, no grade III or above AE.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
First Affiliated Hospital Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Hospital, Beijing, Beijing, China
Cancer institute & hospital, chinese academy of medical sciences, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing, China
Peking University Cancer Hospital, Beijing, Beijing, China
The fifth medical center of PLA General Hospital, Beijing, Beijing, China
The First People's Hospital of Foshan, Foshan, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
First Affiliated Hospital of Harbin Medical University, Ha'erbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Eastern Theater General Hospital,QinHuai District Medical Area, Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
First Hospital of Jilin University, Changchun, Jilin, China
Jilin Cancer Hospital, Changchun, Jilin, China
Jinan Central Hospital, Jinan, Shandong, China
Linyi Tumour Hospital, Linyi, Shandong, China
Fudan University Affiliated Zhongshan Hospital, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institution & Hospital, Tianjin, Tianjin, China
Nanfang Hospital of Southern Medical University, Guangzhou, , China
Contact Details
Name: Yan Sun, MD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Shukui Qin, MD
Affiliation: NanJing PLA 81 Hospital
Role: PRINCIPAL_INVESTIGATOR
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