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

NCT07328828 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: HCC-Icaritin-II-CN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• RFS

  For eligible subjects meeting all inclusion/exclusion criteria, study-related data collection will commence within 8 weeks after hepatocellular carcinoma resection. Enrolled patients will enter the treatment phase and receive Icaritin Soft Capsules as postoperative adjuvant therapy. Following treatment initiation, contrast-enhanced CT or MRI will be performed every 3 months (±7 days) to evaluate hepatic lesions and detect potential recurrence or metastasis.

  Follow-up will be conducted for up to 1 year, from baseline through study completion, with imaging assessments performed at protocol-defined intervals.

Study Arms (1)

Study Cohort

OTHER

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.

Drug: Icaritin soft capsules

Interventions

Icaritin soft capsules DRUG

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Clinically or histologically/cytologically confirmed hepatocellular carcinoma (HCC) per the Primary Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition). Archived tissue samples are permitted; if no prior histological diagnosis exists, fresh tumor biopsy must be performed at baseline.
• At least one measurable lesion (RECIST v1.1).
• Child-Pugh score ≤ 7.
• Patients who underwent R0 resection (postoperative pathology report required) and showed no residual intrahepatic lesions on MRI within 8 weeks after surgery.
• At least one high-risk recurrence factor:
• Tumor size ≥ 5 cm;
• Tumor number ≥ 3;
• Microvascular invasion (MVI) grade: M1 or M2;
• Portal vein tumor thrombus resection (Cheng's classification I or II).
• No prior systemic therapy for HCC.
• Normal major organ function, with laboratory results meeting the following
• criteria within 7 days before treatment:
• Hemoglobin \> 80 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;

You may not qualify if:

• Prior systemic therapy for HCC, including chemotherapy, targeted agents (e.g., sorafenib, lenvatinib, regorafenib), immune modulators (anti-PD-1/PD-L1/CTLA-4), or modern Chinese medicine with antitumor indications. Concurrent use of any investigational drug (except antiviral therapy) is excluded.
• Recurrent or metastatic HCC.
• Clinically significant ascites, pleural effusion, or pericardial effusion uncontrolled by medication at enrollment.
• (Note: Imaging-detected ascites without clinical symptoms is permitted.)
• History of abdominal wall fistula, gastrointestinal perforation, refractory unhealed gastric ulcer, or active gastrointestinal bleeding within 6 months before enrollment.
• HCC lesion(s) ≥ 10 cm in any dimension (confirmed by BICR), \> 10 lesions, or HCC volume ≥ 50% of liver volume; macrovascular portal vein tumor thrombosis.
• Major cardiovascular impairment within 12 months before treatment:
• NYHA Class II+ heart failure;
• Unstable angina, myocardial infarction, or stroke;
• Arrhythmia with hemodynamic instability;
• QTc interval \> 480 ms.
• Any surgery within 28 days before the first dose.
• History or current diagnosis of coagulopathy, bleeding, or thrombotic disorders.
• Clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, decompensated cirrhosis, severe fatty liver, hereditary liver disease, liver atrophy, superior vena cava syndrome, or portal hypertension.
• (Note: Portal hypertension without ascites, jaundice, or gastrointestinal bleeding may be considered.)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: January 9, 2026
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)