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

Summary

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

Conditions

• Advanced HBV-Related Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Icaritin

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.

DRUG

HUACHANSU PIAN

HUACHANSU 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences

  collaborator OTHER

• NanJing PLA 81 Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Jinan Central Hospital

  collaborator OTHER

• Linyi Tumour Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

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

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Haikou People's Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Chongqing Traditional Chinese Medicine Hospital

  collaborator OTHER

• Chifeng Municipal Hospital

  collaborator OTHER

• The Affiliated Hospital of Hangzhou Normal University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guilin Medical University, China

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Yunnan Provincial Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• Beijing Shenogen Biomedical Co., Ltd

  lead INDUSTRY

Principal Investigators

• Yan Sun, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• Shukui Qin · NanJing PLA 81 Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-08

Primary Completion

2022-12-30

Completion

2022-12-30

Countries

• China

Study Locations