drugset / Trial / NCT03236636
The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects
Phase 3
Unknown
312 enrolled
Beijing Shenogen Biomedical Co., Ltd
Affiliated Cancer Hospital & Institute of Guangzhou Medical University · collabAnhui Provincial Hospital · collabBeijing Hospital · collabChifeng Municipal Hospital · collabChinese Academy of Medical Sciences · collabChongqing Traditional Chinese Medicine Hospital · collabFirst People's Hospital of Foshan · collabFudan University · collabGuang'anmen Hospital of China Academy of Chinese Medical Sciences · collabGuilin Medical University, China · collabHaikou People's Hospital · collabHebei Medical University Fourth Hospital · collabJinan Central Hospital · collabLinyi Tumour Hospital · collabNanJing PLA 81 Hospital · collabNanfang Hospital, Southern Medical University · collabPeking University Cancer Hospital & Institute · collabShenyang Sixth People's Hospital · collabThe Affiliated Hospital of Hangzhou Normal University · collabThe Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe First Hospital of Jilin University · collabThe Third Xiangya Hospital of Central South University · collabWest China Hospital · collabYunnan Provincial Hospital of Traditional Chinese Medicine · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.
Timeline
- Start
- 2017-09-08
- Primary completion
- 2022-12-30
- Completion
- 2022-12-30
Outcome
Met primary endpoint
release “阿可拉定vs.华蟾素一线治疗晚期肝细胞癌患者的全国多中心注册III期临床试验期中分析达到了预设的主要研究终点。” shenogen.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HUACHANSU PIAN | Unknown | 1.2 g | Oral |
| Subject | Icaritin | Small molecule | 600 mg | Oral |