NCT07328828

Single-Arm Clinical Study of Icaritin Soft Capsules as Adjuvant Therapy for Hepatocellular Carcinoma Patients at High Risk of Postoperative Recurrence

Single-Center, Prospective, Single-Arm Clinical Study Protocol of Icaritin Soft Capsules as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors Post-Resection

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[SAEs\]).

Conditions

• RFS

Interventions

Type	Name	Description
DRUG	Icaritin soft capsules	Within 8 weeks after R0 resection for hepatocellular carcinoma, patients begin adjuvant therapy with Icaritin Soft Capsules until disease recurrence, with treatment duration not exceeding 1 year. Icaritin Soft Capsules are administered orally at 600 mg twice daily, taken within 30 minutes after morning and evening meals with warm water. If a dose is missed and cannot be taken within 2 hours after a meal, patients should skip the missed dose and resume the next scheduled dose without make-up administration.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2026-06-30
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China