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Could a herbal extract keep liver cancer away after surgery?

NCT ID NCT07328828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether icaritin soft capsules, taken daily for up to a year, can help prevent liver cancer from coming back in patients who had surgery to remove their tumor. Twenty adults with high-risk features for recurrence will take the capsules twice a day. The main goal is to see how long they stay cancer-free, and the study also tracks side effects and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
icaritin soft capsules
What this could lead to
If it works, this could point toward a way to lower the chance of liver cancer coming back after surgery.
What could go wrong
This is a very early, small study with only 20 people, so results may not apply widely. The treatment is taken until recurrence or for up to a year, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • the Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.