The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects

Recruiting in Palo Alto (17 mi)

+26 other locations

Overseen by Shukui Qin

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 enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.

Research Team

Yan Sun, MD

Principal Investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Shukui Qin

Principal Investigator

NanJing PLA 81 Hospital

Eligibility Criteria

Inclusion Criteria

①Marrow: There is no blood transfusion and use of hematopoietic cell stimulating agent, including granulocyte colony stimulating factor (G-CSF)within 14 days before screening, platelet≥60×10E9/L, hemoglobin≥ 85g/L, white blood cell≥3.0×10E9/L; After a thorough measurement of the patient's condition, the above three items can be appropriately relaxed by the principal researchers at the research centre as: platelet 50 ~60×10E9/L, hemoglobin 80~85g/L, white blood cell 2.5 ~3.0×10E9/L (contains critical values);

②Liver: Total bilirubin≤1.5 times of the upper limit of normal(ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤5 × ULN; albumin≥ 28g/L;

④ Kidney: Serum creatinine≤ 1.5 x ULN, or creatinine clearance rate≥ 50ml/min; 13) If HBV-DNA≥104 copies/ml(2000IU/ml), antiviral therapy must be done first, the patient can be included in the group until HBV-DNA<104 copies /ml(2000IU/ml); and continue to take antiviral drugs, monitor liver function and hepatitis B virus load; 14) Women of childbearing age must receive pregnancy tests 14 days before treatment and the results are negative; Men of childbearing age need effective contraception during treatment and within 3 months after treatment; 15) Patients are volunteered to join the study, sign the informed consent, have good compliance and cooperate with follow-up; 16) The subjects do not participate in other clinical trials within 4 weeks before screening; If the subject fails in other test screening, but meets the requirements of this test, then can be enrolled.

Treatment Details

Interventions

• HUACHANSU PIAN (Herbal Medicine)
• Icaritin (Flavonoid)

Participant Groups

Group I: Icaritin Experimental Treatment 1 Intervention

Icaritin: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: HUACHANSU PIAN Active Control 1 Intervention

HUANCHANSU PIAN:Take orally 4 tablets/time(0.3g/tablet), 3 times/day(30 minutes after breakfast, lunch and dinner), 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+

Guilin Medical University, China

Collaborator

Trials

14

Recruited

5,700+

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

Chinese Academy of Medical Sciences

Collaborator

Trials

336

Recruited

494,000+

Dr. Ma

Chinese Academy of Medical Sciences

Chief Medical Officer since 2023

MD from Shanghai Medical College of Fudan University

Dr. Wu

Chinese Academy of Medical Sciences

Chief Executive Officer since 2009

PhD in Biochemistry and Pharmacology from the University of Konstanz, Germany

The First Hospital of Jilin University

Collaborator

Trials

281

Recruited

1,598,000+

Yang Yi

The First Hospital of Jilin University

Chief Executive Officer

Doctor of Medicine

Wang Zan

The First Hospital of Jilin University

Chief Medical Officer

Doctor of Medicine

The Third Xiangya Hospital of Central South University

Collaborator

Trials

119

Recruited

330,000+

Jiancheng Li

The Third Xiangya Hospital of Central South University

Chief Executive Officer since 2023

MD from Central South University

Hongyang Wang

The Third Xiangya Hospital of Central South University

Chief Medical Officer since 2024

PhD in Medicine from Central South University

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborator

Trials

67

Recruited

19,000+

Professor Xu Kecheng

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Chief Executive Officer since 2010

MD in General Oncology and Gastroenterology

Professor Niu Lizhi

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Chief Medical Officer

PhD in Oncology

Haikou People's Hospital

Collaborator

Trials

8

Recruited

9,300+

Yunnan Provincial Hospital of Traditional Chinese Medicine

Collaborator

Trials

2

Recruited

50,300+

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