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

Summary

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

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

DRUG

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

Sorafenib Tosylate Tablets

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Eastern Theater General Hospital,QinHuai District Medical Area

  collaborator UNKNOWN

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• General Hospital of Chinese Armed Police Forces

  collaborator OTHER

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

  collaborator OTHER

• Jinan Central Hospital

  collaborator OTHER

• Linyi Cancer Hospital

  collaborator UNKNOWN

• 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

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• 307 Hospital of PLA

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Beijing YouAn Hospital

  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, MD · NanJing PLA 81 Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-20

Primary Completion

2022-02-08

Completion

2022-02-08

Countries

• China

Study Locations