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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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