Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.

400mg/time, 2 tablets/time(2×200mg/tablet), 2times/day(Fasting), take orally, continuous administration until reach the standard of termination.

Icaritin

Sorafenib Tosylate Tablets

Yan Sun, MD

Shukui Qin, MD

The primary efficacy index of this study is to compare the OS of the two groups.

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.

The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects

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

Baseline expression or expression changes of programmed cell death ligand 1 (PD-L1), heterogeneous ribonucleoprotein A2/B1 (hnRNPAB1) and interleukin -6 (IL-6) and so on.

Genetic variation(Liver cancer driver genes and hotspot gene mutations, such as IDH1/2, JAK2/3, PD-L1/2), expression levels of oncogenes and immune related genes(Gene copy number and RNA expression level) and epigenetics cohort analysis

OS is defined as the time from randomization to died from any cause. For the subjects who failed to visit, deletion is performed on the final date of knowing the survival of the subjects, for subjects who still survive, deletion is performed on the data expiration date.

PFS is defined as the date from randomization to the first radiographic record of disease progression or death (whichever occurs first). See the Statistical Analysis Plan (SAP) for the definition of PFS deletion rule.

TTP is defined as the date from randomization to the first radiographic record of disease progression, see the Statistical Analysis Plan(SAP) for the definition of TTP deletion rule.

ORR is defined as the proportion of subjects achieving optimal overall efficacy such as CR or partial remission (PR).

DCR is defined as the proportion of subjects achieving optimal overall efficacy such as CR, PR or stable disease (SD).

Quality of life (QOL) changes: Quality of life scores are assessed with EORTC QLQ-C30 and compared with baseline values.

Quality of life (QOL) changes: Quality of life scores are assessed with EORTCQLQ-HCC-18 and compared with baseline values.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eastern Theater General Hospital,QinHuai District Medical Area

Peking University Cancer Hospital & Institute

Chinese PLA General Hospital

Beijing Hospital

General Hospital of Chinese Armed Police Forces

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Jinan Central Hospital

Linyi Cancer Hospital

The First Affiliated Hospital of Anhui Medical University

Anhui Provincial Hospital

The First Affiliated Hospital with Nanjing Medical University

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Nanfang Hospital, Southern Medical University

First People's Hospital of Foshan

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Tianjin Medical University Cancer Institute and Hospital

The Fourth Hospital of Hebei Medical University

Hunan Cancer Hospital

The First Hospital of Jilin University

307 Hospital of PLA

Fudan University

Henan Cancer Hospital

Jilin Provincial Tumor Hospital

First Affiliated Hospital of Harbin Medical University

First Affiliated Hospital Bengbu Medical College

The First Affiliated Hospital of Soochow University

Tongji Hospital

Beijing YouAn Hospital

Beijing Shenogen Biomedical Co., Ltd

AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.

AK105 200mg intravenously (IV) on day 1 of each 21-day cycle.

AK105 Injection

Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Anlotinib Hydrochloride Capsules

Jia Fan, Doctor

Rui Wang, Master

Weidong Jia, Doctor

Hu Liu, Doctor

Jinglong Chen, Master

Bin Xu, Doctor

Chunyi Hao, Doctor

Haitao Zhao, Doctor

Shunchang Jiao, Master

Yuewei Zhang, Doctor

Jianjun Leng, Doctor

Hong Ren, Master

Shangeng Weng, Doctor

Wenchang Yu, Doctor

Xiaorong Mao, Doctor

Wenhua Zhang

Minshan Chen, Doctor

Zhixiang Jian, Doctor

Wenbo Guo, Doctor

Yajin Chen, Doctor

Bangde Xiang, Doctor

Jie Ma, Doctor

Jinfang Zheng, Doctor

Sichen Wei, Master

Yuemin Nan, Doctor

Yuxian Bai, Doctor

Shundong Cang, Doctor

Hailiang Li, Doctor

Zhiming Wang, Doctor

Shanzhi Gu, Master

Zhiqiang Meng, Doctor

Jian Zhou, Doctor

Zhenggang Ren, Doctor

Shuangsuo Dang, Doctor

Jianqi Lian, Doctor

Wei Yang, Doctor

Qinyang Zhang, Bachelor

Jianrong Wu, Bachelor

Tianqiang Song, Doctor

Tao Han, Doctor

Yamin Zhang, Doctor

Jia Li, Doctor

Xiaobo Lu, Doctor

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.

A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Percentage of subjects achieving complete response (CR) and partial response (PR).

Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects	NCT03236649	Hepatocellular ...	Icaritin Sorafenib Tosyl...	18 Years - 75 Years	Beijing Shenogen Biomedical Co., Ltd
A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)	NCT04344158	Advanced Hepato...	AK105 Injection Anlotinib Hydro... Sorafenib Tosyl...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects	NCT03236649	Hepatocellular ...	Icaritin Sorafenib Tosyl...	18 Years - 75 Years	Beijing Shenogen Biomedical Co., Ltd
A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)	NCT04344158	Advanced Hepato...	AK105 Injection Anlotinib Hydro... Sorafenib Tosyl...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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