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RFSPhase 2NCT07328828

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

A Phase 2 study testing Icaritin soft capsules in people with RFS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
RFS
What is being tested?
Icaritin soft capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Mar 2024to 30 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: 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

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
Being tested
Icaritin soft capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Icaritin soft capsulesDrug

    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 groups in NCT07328828
Study groupRoleWhat they receive
Study CohortOtherWithin 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.
Receives: Drug: Icaritin soft capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328828
Sponsor's protocol ID
HCC-Icaritin-II-CN
Status last verified
Jun 2025
First submitted
19 Jun 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Icaritin soft capsules in people with RFS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS (time frame: Follow-up will be conducted for up to 1 year, from baseline through study completion, with imaging assessments performed at protocol-defined intervals.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07328828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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