RFS
Conditions
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 \[SAEs\]).
Interventions
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.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFS | Follow-up will be conducted for up to 1 year, from baseline through study completion, with imaging assessments performed at protocol-defined intervals. | 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. |
Countries
China
Outcome results
None listed