Could a herbal extract keep liver cancer away after surgery?
NCT ID NCT07328828
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
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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
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Mar 2024
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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 Hide 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
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Other studies related to the condition(s) this trial covers.
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