drugset / Trial / NCT07328828
Single-Arm Clinical Study of Icaritin Soft Capsules as Adjuvant Therapy for Hepatocellular Carcinoma Patients at High Risk of Postoperative Recurrence
Phase 2
Active not recruiting
20 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
Observing the Efficacy and Safety of Icaritin Soft Capsules as Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Patients with High-Risk Factors for Recurrence (A Single-Arm, Single-Center, Prospective Clinical Study Protocol) Detailed Description: Primary Endpoint: Recurrence-Free Survival (RFS) Secondary Endpoints: Recurrence-Free Survival Rate (RFSR) at 6 months and 12 months, Overall Survival (OS) , Quality of Life (QoL) , Safety (including incidence and severity of Adverse Events \[AEs\] and Serious Adverse Events \[SAEs\]).
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-03-01
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Icaritin | Small molecule | 600 mg | Oral |
Indications
No indication recorded.