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

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen by Shukui Qin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Beijing Shenogen Biomedical Co., Ltd

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Yan Sun, MD

Principal Investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Shukui Qin, MD

Principal Investigator

NanJing PLA 81 Hospital

Eligibility Criteria

Inclusion Criteria

Aged between 18 and 75 years old, no gender restriction;

According to "Primary Liver Cancer Diagnosis and Treatment Standard." (2011 Edition) issued by the National Health and Family Planning Commission, advanced or metastatic hepatocellular carcinoma patients who diagnosed by pathology /cytology fail to undergo liver surgery and/or other local treatment (ablation or hepatic artery intervention), or have recurrence and progression after surgery and/or other local treatment;

Not previously accepted first-line system therapy (systemic chemotherapy, molecular targeting, immunotherapy and research medication, etc.) for advanced or metastatic HCC, including but not limited to systematic chemotherapy with oxaliplatin, sorafenib, PD-1/PD-L1 antibody and Icaritin, etc.;

Treatment Details

Interventions

• Icaritin (Flavonoid)
• Sorafenib Tosylate Tablets (Kinase Inhibitor)

Participant Groups

Group I: Icaritin Experimental Treatment 1 Intervention

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.

Group II: Sorafenib Tosylate Tablets Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Beijing Shenogen Biomedical Co., Ltd

Lead Sponsor

Trials

6

Recruited

790+

The First Affiliated Hospital of Bengbu Medical University

Collaborator

Trials

60

Recruited

138,000+

Wang Hongju

The First Affiliated Hospital of Bengbu Medical University

Chief Executive Officer since 2019

PhD, Doctoral Supervisor

Li Duojie

The First Affiliated Hospital of Bengbu Medical University

Chief Medical Officer

Chief Physician, Doctoral Supervisor

Hebei Medical University Fourth Hospital

Collaborator

Trials

126

Recruited

54,800+

Dr. Liu Yunjiang

Hebei Medical University Fourth Hospital

Chief Medical Officer since 2021

MD from Hebei Medical University

Dr. Baoen Shan

Hebei Medical University Fourth Hospital

Chief Executive Officer since 2021

MD from Hebei Medical University

Chinese Academy of Medical Sciences

Collaborator

Trials

373

Recruited

512,000+

Wang Chen

Chinese Academy of Medical Sciences

Chief Executive Officer since 2011

MD from Peking Union Medical College

Zhao Yupei

Chinese Academy of Medical Sciences

Chief Medical Officer since 2015

MD from Peking Union Medical College

Nanfang Hospital of Southern Medical University

Collaborator

Trials

436

Recruited

735,000+

Fan Fan Hou

Nanfang Hospital of Southern Medical University

Chief Executive Officer

MD, Southern Medical University

Jian Sun

Nanfang Hospital of Southern Medical University

Chief Medical Officer since 2019

MD, Southern Medical University

The First Affiliated Hospital of Anhui Medical University

Collaborator

Trials

144

Recruited

3,346,000+

Xu Xiaofeng

The First Affiliated Hospital of Anhui Medical University

Chief Medical Officer since 2018

MD from Anhui Medical University

Cao Yunxia

The First Affiliated Hospital of Anhui Medical University

Chief Executive Officer since 2018

MD from Anhui Medical University

Jinan Central Hospital

Collaborator

Trials

35

Recruited

84,300+

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Trials

415

Recruited

284,000+

Han Liang

Tianjin Medical University Cancer Institute and Hospital

Chief Medical Officer since 2004

MD, Medical Faculty, Tianjin Medical College

Hao Xishan

Tianjin Medical University Cancer Institute and Hospital

Chief Executive Officer since 2018

MD, Medical Faculty, Tianjin Medical College

First Affiliated Hospital of Harbin Medical University

Collaborator

Trials

147

Recruited

1,390,000+

Prof. Liu Lianxin

First Affiliated Hospital of Harbin Medical University

Chief Medical Officer

MD, Harbin Medical University

Prof. Yang Baofeng

First Affiliated Hospital of Harbin Medical University

Chief Executive Officer

MD, Harbin Medical University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

Trials

680

Recruited

11,050,000+

Dr. Ning Wu

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Chief Medical Officer since 2020

MD from Shanghai Medical College of Fudan University

Dr. Chen Wang

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Chief Executive Officer since 2021

PhD in Biochemistry and Pharmacology, University of Konstanz