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

NCT07328828 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328828 on ClinicalTrials.gov