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

NCT ID: NCT07328828

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Cohort

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.

Group Type: OTHER

Icaritin soft capsules

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;
• Platelet count ≥ 40 × 10⁹/L;
• Serum albumin ≥ 28 g/L;
• Total bilirubin ≤ 2 × upper limit of normal (ULN);
• AST/ALT ≤ 5 × ULN;
• Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
• Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
• Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN or prothrombin time (PT) ≤ 16 s.
• Ability to swallow and absorb oral medication.
• Negative serum pregnancy test within 7 days before randomization for women of childbearing potential; agreement to use effective contraception during treatment and for 60 days after the last dose.
• Voluntary participation with signed informed consent and expected good compliance.

Exclusion Criteria

• 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.)

• Active autoimmune disease requiring systemic therapy within the past 2 years.
• Live vaccine administered within 30 days before the first dose.
• Hypersensitivity to any component of Epimedium Soft Capsules.
• Uncontrolled active HBV, HCV, or HDV infection; active tuberculosis.
• Pregnancy, lactation, or unwillingness to use contraception during the study.
• Any condition that may contraindicate the study drug, compromise data reliability, increase treatment risk, or affect compliance (e.g., metabolic disorders, abnormal lab results).
• Investigator judgement of unsuitability for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

HCC-Icaritin-II-CN

Identifier Type: -

Identifier Source: org_study_id